CAPA

Lead Electrical Engineer – Hardware Design | Cincinnati, OH

Lead Electrical Engineer – Hardware Design

📍 Location: Cincinnati, Ohio
🏢 Work Arrangement: Onsite
💼 Employment Type: Full-Time, Permanent
🕒 Schedule: 4/10 – Four 10-Hour Days Per Week
🛡️ Security Clearance: Active Clearance Not Required; Ability to Obtain a Secret Clearance Required
✈️ Travel: Occasional
🚚 Relocation Assistance: May Be Considered for an Exceptional Candidate
🚫 Visa Sponsorship: Not Available
👥 People Management: Not Required

Design Mission-Critical Electronics for Extreme Environments

A leading aerospace and defense organization is seeking a Lead Electrical Engineer – Hardware Design to lead the design, development, testing and qualification of ruggedized electronic systems for advanced ordnance applications.

This is a hands-on senior technical leadership position operating in a fast-paced product-development environment. The successful candidate will combine strong analog, digital and power-electronics design capabilities with technical project leadership, structured problem-solving and the ability to guide products from requirements definition through design, qualification and production support.

The role requires someone capable of working independently with minimal supervision while also collaborating across multidisciplinary engineering teams. The Lead Electrical Engineer will manage several technical priorities simultaneously, mentor other engineers and serve as a primary technical interface with internal and external customers.

Key Responsibilities

Analog and Digital Hardware Design

  • Design analog and digital circuitry for ruggedized aerospace and defense electronics.

  • Develop circuits using analog building blocks such as:

    • Differential amplifiers

    • Operational amplifiers

    • Low-dropout regulators

    • Analog filters

    • Data converters

    • Signal-conditioning circuits

  • Design with digital building blocks such as logic gates, flip-flops, timers and related components.

  • Develop power-conversion and power-conditioning solutions involving:

    • AC/DC conversion

    • DC/DC conversion

    • DC/AC conversion

    • Linear power supplies

    • Switching power supplies

  • Apply sound engineering practices for EMI suppression, ESD protection and short-circuit protection.

  • Support component selection, design trade studies and hardware architecture decisions.

  • Ensure designs can perform reliably in demanding vibration, shock, temperature and humidity conditions.

Circuit Analysis and Verification

  • Perform circuit-tolerance analyses using hand calculations and SPICE-based simulation tools.

  • Evaluate component tolerances, environmental effects and worst-case operating conditions.

  • Define verification methods and acceptance criteria for electrical performance.

  • Analyse test data and determine whether hardware meets requirements.

  • Identify technical risks early and develop appropriate mitigation strategies.

  • Document analysis methods, assumptions, results and engineering recommendations.

Requirements and Compliance

  • Develop, refine and manage electrical and hardware requirements.

  • Translate customer and system-level requirements into implementable hardware designs.

  • Maintain traceability between requirements, design outputs and verification activities.

  • Assess technical compliance throughout the development lifecycle.

  • Support internal and customer reviews of requirements and compliance evidence.

  • Ensure design decisions and changes are appropriately documented.

Testing and Qualification

  • Develop comprehensive test plans, procedures and reports covering:

    • Brassboard testing

    • Design verification

    • Environmental qualification

    • Product-performance testing

    • Firing-properties testing

    • Failure investigation and corrective-action verification

  • Lead and direct laboratory and field-test activities throughout the product-development lifecycle.

  • Coordinate testing with systems, mechanical, manufacturing, quality and test-engineering teams.

  • Troubleshoot hardware using oscilloscopes, function generators, digital multimeters and other standard laboratory equipment.

  • Review test results, investigate anomalies and recommend corrective actions.

  • Ensure testing is appropriately controlled, repeatable and thoroughly documented.

Technical Project Leadership

  • Lead large-scale technical projects from initial concept through completion with minimal supervision.

  • Coordinate technical activities across multiple engineering disciplines.

  • Manage several projects and priorities simultaneously.

  • Establish technical plans, milestones, risks and resource requirements.

  • Track engineering progress and communicate concerns before they affect cost, schedule or performance.

  • Provide technical direction without requiring formal people-management authority.

  • Make well-supported engineering decisions in a dynamic environment with changing customer priorities.

Design Reviews and Customer Interface

  • Prepare materials for and lead formal design reviews throughout the product-development lifecycle.

  • Present technical designs, analyses, risks, verification results and recommendations.

  • Serve as a primary technical interface for internal stakeholders and external customers.

  • Respond clearly and professionally to technical questions and design concerns.

  • Coordinate the resolution of review actions and technical issues.

  • Support final technical presentations and customer acceptance activities.

Failure Investigation and Root-Cause Analysis

  • Lead investigations into hardware failures, nonconformances and test anomalies.

  • Apply structured problem-solving tools such as:

    • 8D

    • Fishbone diagrams

    • Cause-and-effect analysis

    • Fault isolation

    • Corrective and preventive action methodologies

  • Reproduce failures, analyse evidence and identify defensible root causes.

  • Develop, implement and verify effective corrective actions.

  • Communicate investigation findings to engineering teams, customers and leadership.

  • Capture lessons learned and incorporate improvements into future designs.

Engineering Documentation and Change Control

  • Develop clear and accurate technical documentation, including:

    • Test plans

    • Test reports

    • Engineering drawings

    • Design analyses

    • Requirements and compliance documentation

    • Design-review materials

    • Failure-investigation reports

  • Create and process Engineering Orders and Engineering Change Proposals.

  • Support configuration management and formal change-control activities.

  • Maintain appropriate documentation throughout the product lifecycle.

  • Ensure technical records meet internal, contractual and regulatory expectations.

Proposal and Team Support

  • Provide material, labour and technical estimates for Requests for Proposals.

  • Contribute to technical approaches, schedules, risks and assumptions.

  • Support programme planning and new-business activities.

  • Mentor electrical engineers and support their technical development.

  • Promote effective collaboration, engineering discipline and knowledge sharing.

Required Qualifications

Candidates must meet one of the following education and experience combinations:

  • Bachelor’s degree in Electrical Engineering, Computer Engineering or a related technical discipline with at least nine years of relevant experience.

  • Graduate degree in Electrical Engineering or a related discipline with at least seven years of relevant experience.

  • At least 13 years of directly relevant professional experience in place of a degree.

Additional required experience includes:

  • At least five years of experience designing with basic analog building blocks, including differential amplifiers, operational amplifiers, LDOs, filters and data converters.

  • At least five years of experience designing with digital building blocks, including logic gates, flip-flops and timers.

  • At least four years of experience with power-conversion concepts, including AC/DC, DC/DC, DC/AC, linear and switching supplies.

  • At least five years of experience troubleshooting electronic hardware using standard laboratory equipment.

  • At least four years of experience with schematic-capture or PCB-layout tools such as Altium or PADS.

  • At least four years of experience leading a large-scale technical project from beginning to completion with minimal guidance.

  • At least four years of experience preparing for and participating in internal or external design reviews.

  • At least four years of experience producing formal technical documentation such as test plans, test reports and engineering drawings.

  • Strong written and verbal communication skills.

  • Ability to work both independently and within a multidisciplinary team.

  • Ability to manage several technical priorities simultaneously.

  • Ability to meet all eligibility requirements for a US Secret security clearance.

  • Current authorization to work in the United States without employer sponsorship.

An active security clearance is not required at the time of application.

Preferred Qualifications

  • Experience designing ruggedized electronics for aerospace, defense or ordnance applications.

  • At least four years of experience working with:

    • Temperature sensors

    • MEMS accelerometers

    • Differential-pressure sensors

    • Gyroscopes

  • At least five years of experience with serial communication interfaces such as UART, SPI and I²C.

  • At least five years of structured root-cause analysis experience.

  • Experience applying design practices for EMI suppression, ESD protection and short-circuit protection.

  • At least five years of power-supply and power-conditioning design experience.

  • Experience designing electronic systems for extreme vibration, shock, temperature and humidity environments.

  • Experience with energetic-material interfaces and associated testing.

  • Experience supporting firing-device interfaces, including exploding-foil and low-energy exploding-foil initiators.

  • Experience working with lead charges, boosters or related energetic components.

Safety and Arming Systems Experience

Highly desirable experience includes:

  • Designing Electronic Safety and Arming Devices or Ignition Safety Devices.

  • Applying MIL-STD-1316 and MIL-STD-1901A.

  • Developing ESAD, ESAF or ISD solutions for defense applications.

  • Presenting safety-device designs to formal review boards such as:

    • Air Force Safety Review Board

    • Fuze and Ignition System Technical Review Panel

    • Navy Nuclear Weapons System Safety Board

  • Supporting qualification, compliance and safety-review activities for ordnance electronics.

The Ideal Candidate

The strongest candidate will be able to demonstrate:

  • End-to-end ownership of complex electrical hardware designs.

  • Strong analog, digital and power-electronics expertise.

  • Hands-on circuit analysis, laboratory testing and troubleshooting capabilities.

  • Experience designing electronics for harsh or extreme environments.

  • Leadership of multidisciplinary technical projects from concept through qualification.

  • Confidence leading formal internal and customer design reviews.

  • Structured investigation and resolution of difficult hardware failures.

  • Strong technical writing and documentation skills.

  • Experience mentoring engineers without requiring formal supervisory authority.

  • The ability to communicate effectively with engineering teams, programme leadership and customers.

  • Flexibility to respond to changing technical and programme priorities.

Work Environment and Benefits

The position operates within a fast-paced aerospace and defense engineering environment and requires close collaboration across electrical, mechanical, systems, test, manufacturing, quality and programme teams.

Employees work a 4/10 schedule, completing four 10-hour shifts each week. The organization offers a comprehensive benefits package and may consider relocation support for an exceptional candidate.

Equal Opportunity

The organization is an Equal Opportunity Employer and considers qualified applicants without discrimination based on any status protected under applicable federal, state or local law.

 

Environmental Manager | Manufacturing & Environmental Compliance | Mapleton, IL

Environmental Manager

📍 Location: Mapleton, IL
🏭 Industry: Manufacturing / Heavy Industrial Operations
💼 Employment Type: Full-Time
🚫 Visa Sponsorship: Not Available
🚚 Relocation Assistance: Available
✈️ Interview Travel: Reimbursed
💰 Compensation: Competitive Base Salary + Bonus Eligible

Overview

A leading industrial manufacturing organization is seeking an Environmental Manager to provide strategic leadership and oversight of environmental compliance programs at a large-scale manufacturing facility.

This role will be responsible for managing environmental programs, ensuring regulatory compliance, driving continuous improvement initiatives, and partnering with operational leaders to maintain safe, compliant, and sustainable operations.

The successful candidate will serve as the site's environmental subject matter expert while mentoring personnel across all levels of the organization and helping drive environmental performance excellence.

Key Responsibilities

Environmental Compliance & Regulatory Management

  • Lead environmental compliance programs across the facility.

  • Ensure compliance with federal, state, and local environmental regulations.

  • Interpret and apply environmental regulations and permit requirements.

  • Support regulatory inspections, audits, and agency interactions.

  • Maintain environmental permits and compliance documentation.

Air, Water & Waste Programs

  • Manage air compliance programs and permit requirements.

  • Oversee drinking water and wastewater compliance activities.

  • Ensure proper hazardous waste management and disposal practices.

  • Monitor environmental performance and identify potential risks.

  • Develop corrective actions and improvement initiatives.

EHS Leadership

  • Provide leadership, mentoring, and guidance to hourly, salaried, and management personnel.

  • Promote a strong environmental and safety culture throughout the facility.

  • Partner with operations leaders to drive compliance and risk reduction.

  • Support site-wide EHS objectives and business initiatives.

Auditing & Risk Management

  • Conduct environmental audits and compliance assessments.

  • Evaluate program effectiveness and identify improvement opportunities.

  • Monitor environmental performance trends and key metrics.

  • Recommend and implement corrective and preventative actions.

Training & Development

  • Ensure environmental training programs meet regulatory requirements.

  • Support employee awareness and compliance initiatives.

  • Provide environmental expertise and coaching to facility leadership teams.

Required Qualifications

Education

✔ Bachelor's Degree in Environmental Science, Engineering, EHS, Chemistry, or a related technical discipline.

Experience

✔ 5+ years of environmental compliance, environmental engineering, or EHS experience.

✔ Experience managing environmental programs within industrial or manufacturing environments.

✔ Strong knowledge of environmental regulations and compliance requirements.

✔ Previous leadership or management experience.

Highly Preferred Experience

Environmental Compliance

  • Air Compliance Programs

  • Air Permit Management

  • Title V Permitting

  • Environmental Reporting

  • Regulatory Agency Interaction

Water Programs

  • Drinking Water Compliance

  • Wastewater Treatment

  • Water Permitting

  • Environmental Monitoring

Hazardous Materials

  • Hazardous Waste Regulations

  • Waste Management Programs

  • Environmental Risk Assessments

Preferred Industry Backgrounds

Candidates from the following industries are strongly preferred:

  • Foundry Operations

  • Oil & Gas

  • Paper Mills

  • Heavy Manufacturing

  • Industrial Processing

  • Chemical Manufacturing

  • Metals Processing

Core Competencies

Environmental Health & Safety (EHS)

  • Environmental Compliance

  • Regulatory Interpretation

  • Environmental Auditing

  • Environmental Program Management

Risk Management

  • Risk Assessment

  • Regulatory Risk Mitigation

  • Compliance Monitoring

  • Incident Prevention

Leadership

  • Team Development

  • Cross-Functional Collaboration

  • Change Management

  • Stakeholder Engagement

Continuous Improvement

  • Problem Solving

  • Process Improvement

  • Sustainability Initiatives

  • Operational Excellence

Screening Questions

  1. Do you hold a Bachelor's degree in Environmental Science, Engineering, EHS, Chemistry, or a related technical field?

  2. How many years of environmental compliance or EHS experience do you have?

  3. Do you have direct experience managing air compliance programs and environmental permits?

  4. Have you worked with drinking water and wastewater compliance programs?

  5. Do you have experience managing hazardous waste programs and regulations?

  6. Have you worked within a manufacturing, foundry, oil & gas, paper mill, or similar industrial environment?

  7. Do you have previous leadership or management experience?

  8. Are you comfortable relocating to Mapleton, Illinois?

  9. Have you interacted directly with regulatory agencies and environmental auditors?

  10. What environmental permits and compliance programs have you personally managed?

Ideal Candidate Profile

The ideal candidate will be an experienced environmental leader who combines strong technical compliance expertise with the ability to influence and develop teams.

They will possess:

  • Deep knowledge of environmental regulations and permitting.

  • Significant experience with air compliance and air permitting.

  • Strong understanding of wastewater, drinking water, and hazardous waste programs.

  • Previous leadership experience within industrial manufacturing environments.

  • Excellent communication and relationship-building skills.

  • A proactive approach to risk reduction and continuous improvement.

  • The ability to work collaboratively across operations, engineering, maintenance, and leadership teams.

Candidate Snapshot

Requirement

Details

Experience

5+ Years Environmental Compliance/EHS

Education

Bachelor's Degree Required

Leadership

Management Experience Required

Compliance Expertise

Air, Water & Waste Programs

Industry

Manufacturing / Industrial Operations

Preferred Industries

Foundry, Oil & Gas, Paper Mill

Location

Mapleton, IL

Travel

Occasional

Relocation

Available

Bonus

Eligible

What Makes Someone Successful in This Role?

  • Strong environmental compliance and permitting expertise.

  • Proven success managing environmental programs in industrial settings.

  • Ability to lead and influence teams across all organizational levels.

  • Experience navigating complex regulatory environments.

  • Strong problem-solving and risk management capabilities.

  • Passion for environmental stewardship and operational excellence.

  • Ability to balance compliance, sustainability, and business objectives.

Why This Opportunity?

✅ Lead environmental strategy at a large-scale industrial facility.

✅ Significant ownership and visibility within plant leadership.

✅ Opportunity to drive meaningful environmental improvements and sustainability initiatives.

✅ Relocation assistance and bonus eligibility available.

✅ Work within a highly respected manufacturing organization committed to safety, compliance, and operational excellence.

 

Quality Assurance Regional Manager – Albert Lea, MN

Quality Assurance Regional Manager

📍 Location: Albert Lea, Minnesota (Oversight of Multiple Manufacturing Sites)
💼 Employment Type: Full-Time
💰 Base Salary: $130,000 – $145,000
🚚 Relocation Assistance: Available for Ideal Candidates
✈️ Travel: Frequent Regional Travel Required
🚫 Visa Sponsorship: Not Available

Overview

A growing manufacturer in the food and nutrition sector is seeking a Quality Assurance Regional Manager to lead quality and food safety operations across multiple production facilities in Minnesota.

This leadership role is responsible for driving food safety, regulatory compliance, quality system effectiveness, continuous improvement, and team development while partnering closely with Operations, Production, R&D, and Commercial teams.

The successful candidate will be a strong people leader with deep expertise in FDA-regulated manufacturing environments and a proven ability to influence cross-functional teams.

Key Responsibilities

Quality & Food Safety Leadership

  • Lead quality assurance programs across multiple manufacturing sites.

  • Ensure compliance with FDA, HACCP, SQF, customer, and internal quality standards.

  • Drive continuous improvement initiatives focused on food safety, quality, and operational excellence.

  • Oversee internal audit programs, CAPA processes, and compliance activities.

  • Lead root cause investigations and implement sustainable corrective actions.

Team Leadership

  • Develop, coach, and mentor regional quality teams.

  • Establish and communicate performance goals using SMART objectives.

  • Build a culture of accountability, food safety, and continuous improvement.

  • Deliver food safety and quality training programs.

Cross-Functional Collaboration

  • Partner with Production, R&D, Commercial, and Operations teams to support product launches and process improvements.

  • Support commercialization activities, change control processes, and new product introductions.

  • Provide quality leadership during customer visits, regulatory inspections, and external audits.

Systems & Compliance

  • Ensure effective implementation of food safety and quality management systems.

  • Monitor and improve key metrics including:

    • First Pass Quality

    • Customer Complaints

    • CAPA Effectiveness

    • Inventory Health

    • Compliance Performance

    • Environmental & Sanitation Programs

  • Apply SPC and data-driven methodologies to improve process performance.

Required Qualifications

  • Bachelor's Degree in Science or a related field.

  • 10+ years of Quality Assurance experience within:

    • Food Manufacturing

    • Beverage Manufacturing

    • Dietary Supplements

    • Pharmaceutical or Medical Device Manufacturing

  • Management experience leading quality teams.

  • Strong knowledge of:

    • FDA Regulations

    • HACCP

    • SQF

    • Food Safety Programs

  • U.S. Citizen or Permanent Resident.

Preferred Experience

  • Multi-site quality leadership experience.

  • Career progression across multiple functions including:

    • Production

    • R&D

    • Quality

  • PCQI certification.

  • Strong experience working with cross-functional teams.

  • Statistical Process Control (SPC) expertise.

  • Project management and continuous improvement experience.

Key Skills

✔ Quality Assurance Leadership
✔ FDA Compliance
✔ HACCP & SQF Programs
✔ Food Safety Systems
✔ CAPA Management
✔ Root Cause Analysis
✔ Internal Auditing
✔ SPC & Data Analysis
✔ Team Development
✔ Cross-Functional Leadership

Ideal Candidate

The ideal candidate has a strong quality leadership background within food or beverage manufacturing and has progressed through multiple operational disciplines such as Production, R&D, and Quality.

They will bring:

  • Multi-site quality management experience.

  • Strong food safety and regulatory expertise.

  • Proven success leading cross-functional initiatives.

  • Excellent leadership, coaching, and communication skills.

  • A track record of driving continuous improvement and quality culture transformation.

Screening Questions

  1. Do you have experience in the food and beverage manufacturing industry?

  2. Do you have hands-on experience with HACCP, SQF, and food safety systems?

  3. Are you a U.S. Citizen or Permanent Resident?

  4. Have you successfully partnered with cross-functional teams across operations, R&D, and quality?

  5. Have you held roles in multiple functions such as Production, R&D, and Quality during your career?

Candidate Snapshot

Requirement

Details

Experience

10+ Years

Seniority

Director Level

Education

Bachelor's Degree

Industry

Food & Beverage Manufacturing

Management Experience

Required

Travel

Frequent

Multi-Site Oversight

Preferred

Relocation

Available

Why Consider This Opportunity?

  • Lead quality operations across multiple manufacturing facilities.

  • High visibility role with direct impact on food safety and operational excellence.

  • Strong career growth opportunities within a growing organization.

  • Collaborative environment with significant cross-functional leadership exposure.

  • Opportunity to shape quality strategy and drive continuous improvement initiatives across multiple sites.

 

Senior Software Quality Engineer – Medical Devices | Limerick, IRE

Senior Software Quality Engineer

📍 Location: Limerick, Ireland
🏢 Work Model: Hybrid – Minimum 4 days onsite
💼 Employment Type: Full-Time
💰 Salary: €60,000 – €70,000
✈️ Travel: Occasional
🎓 Education: Bachelor’s Degree in Engineering or related technical field

Role Overview

A leading global medical technology organization is seeking a Senior Software Quality Engineer to support research and development programs focused on innovative medical technologies.

This role will be responsible for establishing and maintaining software quality processes, regulatory compliance, and design control systems to ensure the successful development and delivery of high-quality medical device software.

The position plays a key role in new product development, manufacturing transfer, and quality management system implementation, ensuring software systems meet both regulatory standards and customer expectations.

Key Responsibilities

Software Quality & Compliance

  • Develop and maintain software quality strategies, processes, and procedures

  • Ensure compliance with medical device regulatory standards including:

    • FDA 21 CFR Part 820

    • FDA 21 CFR Part 11

    • ISO 13485

    • ISO 14971

    • IEC 62304

    • EU MDR 2017/745

  • Guide computer system validation (CSV) and electronic records compliance

Design & Development Quality

  • Support software lifecycle activities including:

    • Requirements management

    • Software development planning

    • Risk management

    • Verification & validation (V&V)

  • Facilitate design reviews and functional reviews

  • Review and approve technical documentation including:

    • Design documentation

    • Verification and validation protocols

    • Product drawings

Cross-Functional Collaboration

  • Represent the Quality function within New Product Development teams

  • Work closely with R&D, manufacturing, and engineering teams

  • Support technology transfer initiatives between development and manufacturing environments

Continuous Improvement & Quality Systems

  • Contribute to the development and implementation of quality management systems

  • Support CAPA investigations and remediation activities

  • Drive improvements in test coverage, software reliability, and system performance

Data Analysis & Problem Solving

  • Apply statistical tools and quality methodologies to:

    • Identify root causes

    • Analyse product or process issues

    • Implement corrective actions

Required Qualifications

  • Bachelor’s degree in:

    • Software Engineering

    • Electrical Engineering

    • Biomedical Engineering

    • Mechanical Engineering

    • Or a related technical discipline

  • 6–7 years of professional experience in engineering or quality roles

  • At least 4+ years of experience in software development lifecycle or software quality

  • Strong understanding of medical device regulatory requirements

  • Experience with:

    • Software validation

    • Design controls

    • Risk management processes

  • Strong analytical, problem-solving, and communication skills

Preferred Experience

  • Experience in medical devices, healthcare technology, or regulated environments

  • Familiarity with CAPA processes and audit remediation

  • Knowledge of:

    • Six Sigma methodologies

    • Root cause analysis tools

    • Statistical sampling techniques

  • Experience working on cross-functional product development teams

Ideal Candidate

The ideal candidate is a software quality specialist within regulated industries who:

  • Has strong experience in medical device software compliance

  • Understands design controls and validation processes

  • Can support new product development programs

  • Works effectively with cross-functional engineering teams

  • Applies structured problem-solving and quality methodologies

Why Join

  • Opportunity to work on cutting-edge medical technologies

  • Collaborative engineering and research environment

  • Work with global teams driving healthcare innovation

  • Strong culture of professional growth and technical excellence

 

Senior Quality Engineer – Design Assurance | Medical Devices | Limerick, Ireland

Senior Quality Engineer – Design Assurance

📍 Location: Limerick, Ireland
🏢 Work Model: Hybrid – Minimum 4 days onsite
💼 Employment Type: Full-Time
💰 Salary: €60,000 – €70,000
✈️ Travel: Occasional
🎓 Education: Bachelor’s Degree in Engineering or related discipline preferred

Role Overview

A global medical technology organization is seeking a Senior Quality Engineer – Design Assurance to support new product development and sustaining engineering projects.

In this role, you will act as the Quality representative on cross-functional project teams, ensuring that products meet global regulatory requirements and internal quality standards throughout the entire product lifecycle—from concept and development through product launch and ongoing support.

You will play a critical role in design controls, risk management, verification & validation, and regulatory compliance, helping deliver high-quality medical technologies that improve patient care.

Key Responsibilities

Design Assurance & Product Development

  • Represent the Quality function on project core teams for new product development and design change projects

  • Support product lifecycle activities from concept through launch and maintenance

  • Ensure compliance with design control, risk management, and change control processes

Risk Management & Compliance

  • Lead risk management activities throughout the product development lifecycle

  • Support compliance with key standards such as:

    • ISO 13485

    • ISO 14971

    • IEC 60601

    • IEC 62304

    • EU MDR

  • Ensure regulatory requirements are integrated into development activities

Verification & Validation

  • Support development and execution of verification and validation (V&V) strategies

  • Review and approve test plans, protocols, and reports

  • Evaluate statistical approaches and challenge testing methodologies where necessary

  • Authorise and assess deviations during testing activities

Documentation & Quality Systems

  • Contribute to the creation and maintenance of Design History File (DHF) documentation

  • Support Quality Management System (QMS) activities including:

    • CAPA investigations

    • Field assessments

    • Operational engineering evaluations

  • Ensure accurate documentation and traceability across development programs

Issue Management & Continuous Improvement

  • Support failure investigations and root cause analysis

  • Manage software issue tracking in accordance with IEC 62304

  • Promote a strong quality culture across project teams

Required Qualifications

  • Bachelor’s degree in Engineering or related technical discipline
    (Equivalent experience considered)

  • Minimum 5+ years of experience in Quality Engineering within a regulated environment

  • Strong knowledge of:

    • ISO 13485

    • QSR / FDA quality requirements

    • ISO 14971 risk management

    • Statistical analysis techniques

  • Experience with:

    • Design assurance processes

    • Design controls and change control

    • Risk management methodologies

  • Strong written and verbal communication skills

  • Ability to manage multiple projects and priorities simultaneously

Preferred Experience

  • Experience with EU Medical Device Regulation (MDR)

  • Knowledge of:

    • IEC 62304 (medical device software lifecycle)

    • IEC 62366 (usability engineering)

  • Experience supporting software-enabled medical devices

  • Experience working with cross-functional product development teams

Ideal Candidate

The ideal candidate is a Quality Engineer experienced in regulated product development who:

  • Has strong expertise in design assurance and risk management

  • Understands the medical device regulatory landscape

  • Can effectively influence cross-functional engineering teams

  • Demonstrates strong attention to detail and analytical thinking

  • Promotes a patient-first approach to quality and compliance

 

Supplier Technical Engineer – Supplier Quality & Process Improvement (On-site, San Diego)

⚙️ Supplier Technical Engineer

📍 Location: San Diego, CA (On-site)
💼 Employment Type: Full-Time
🏭 Industry: Energy
📦 Function: Supply Chain / Supplier Quality
🛂 Visa Sponsorship: Not available
🎯 Level: Associate (2–5 years’ experience)

🌟 About the Role

We are seeking a Supplier Technical Engineer to support supplier quality, process reliability, and continuous improvement across a global supply chain. This role plays a critical part in ensuring supplier performance meets high technical and quality standards while partnering closely with internal stakeholders and external suppliers to resolve issues and drive long-term improvements.

If you enjoy working at the intersection of engineering, quality, and supplier collaboration, this is a strong opportunity to build impact early in your career.

🔧 Key Responsibilities

  • Support resolution of supplier-related quality issues and process gaps

  • Provide conclusions and recommendations for quality improvements

  • Partner with suppliers on continuous improvement initiatives

  • Implement and monitor supplier process controls, evaluations, audits, and corrective actions

  • Support supplier qualification for new products and components

  • Identify root causes of quality problems and develop short- and long-term action plans

  • Maintain documentation related to inspections, evaluations, and quality records

🧠 Core Competencies You’ll Use Daily

Quality & Continuous Improvement

  • Apply quality management tools and techniques

  • Use inspections, walkthroughs, and evaluation tools

  • Track quality indicators and support improvement efforts

Problem Solving

  • Identify and document issues and solution options

  • Use data and diagnostics to assess root cause

  • Balance risk, cost, and impact when recommending solutions

Collaboration & Communication

  • Work cross-functionally with engineering, manufacturing, and supply chain

  • Communicate clearly with suppliers and internal teams

  • Contribute to collaborative problem-solving sessions

Attention to Detail

  • Ensure accuracy in documentation and reporting

  • Use checklists and verification methods to avoid errors

  • Learn from past issues to improve future outcomes

Time & Priority Management

  • Manage multiple tasks and priorities simultaneously

  • Respond to operational needs while progressing project work

🎓 Background & Experience

Required

  • Bachelor’s degree in Supply Chain, Engineering, or related field

  • 2–5 years of experience in supplier quality, manufacturing, or technical supply chain roles

Preferred

  • Experience in Supplier Quality Engineering (SQE)

  • Familiarity with investment casting and airfoil components (e.g., blades, nozzles)

  • Exposure to manufacturing environments or technical suppliers

💰 Compensation & Benefits

  • Salary Range: $89,210 – $133,810

  • Benefits: Full benefits package

  • Bonus: Not eligible

  • Relocation: Not available

  • Travel: None required

 

Manufacturing Operations Manager | $106K–$150K | Consumer Products | Sanford, ME

Manufacturing Operations Manager

Location: Sanford, Maine
Job ID: 167229
Employment Type: Full-Time

💵 Compensation:

  • Base Salary: $106,000 – $150,000/year

  • Bonus Eligible: No

  • Commission: No

  • Overtime Eligible: No

🎁 Benefits:

  • Full benefits package (medical, dental, vision, 401k, etc.)

  • Relocation assistance available for the ideal candidate

  • Paid time off (PTO) and holidays

  • Career development and advancement support

  • Opportunities for continuous improvement training (Lean, Six Sigma, etc.)

Lead. Innovate. Transform.

Are you a manufacturing leader ready to take the next step in your career? This exciting opportunity offers the chance to drive operational excellence, lead high-performing teams, and influence end-to-end production strategies at a dynamic consumer products facility in Sanford, Maine.

You’ll oversee production, warehouse, and finishing operations while fostering a safety-first, quality-driven, and continuous improvement culture. Bring your passion for innovation, people leadership, and efficiency—and make a measurable impact on global supply chain performance.

What You’ll Be Responsible For

🔧 Operations Leadership

  • Oversee daily operations across production, making, finishing, and warehouse areas

  • Lead supervisory teams and technicians to meet KPIs around quality, safety, and efficiency

  • Drive a culture of accountability, performance, and collaboration

  • Partner cross-functionally with Engineering, Maintenance, Quality, and EH&S to maximize productivity

  • Champion Factory Performance & Reliability (FP&R) standards including People Capability, Visual Workplace, and Continuous Improvement

  • Act as a visible, hands-on leader during audits, SOP reviews, and daily operations

  • Build contingency plans to ensure business continuity during disruptions

💰 Financial Oversight

  • Co-own plant financial performance with site leadership

  • Drive savings initiatives through labor cost optimization and FTG (Fund-the-Growth) programs

  • Analyze variances in materials, labor, and output to improve financial forecasting

  • Optimize inventory, capital expenditures, and operating expenses to improve cash flow

  • Monitor and revise site KPIs to align with evolving business goals

👥 People & Culture

  • Execute labor strategies that promote employee relations, retention, and engagement

  • Build and mentor a high-performing workforce, empowering both salaried and hourly teams

  • Develop internal talent pipelines while fostering a culture of recognition and inclusion

✅ Quality, Compliance & Process Excellence

  • Ensure all production activities align with GMP, FDA, and safety standards

  • Own decisions regarding out-of-spec raw materials, WIP, and finished goods

  • Guarantee team proficiency with SOPs for lot tracking, release procedures, code dating, and traceability

  • Lead implementation of corrective/preventive actions for non-conformances

  • Ensure validated cleaning, sanitization, and changeover procedures are followed

  • Facilitate successful technology transfers for new products and processes

⚙️ Process & Equipment Optimization

  • Set annual site goals for process capability; monitor and report on monthly progress

  • Ensure process control tolerances, calibration routines, and SOP accuracy

  • Identify and resolve equipment constraints in partnership with technical teams

  • Oversee preventive maintenance and ensure team training on cleaning and batch procedures

What You Bring

  • Bachelor’s Degree in Engineering or related discipline (required)

  • 8+ years of progressive leadership in manufacturing operations

  • Strong background in GMP, FDA/regulated environments, and ISO/OSHA standards

  • Solid understanding of Quality systems and manufacturing audits

  • Advanced proficiency with digital tools (e.g., Google Suite, Data Studio)

  • Experience leading cross-functional teams and navigating matrixed environments

Preferred Qualifications

  • SAP, WMS, and plant floor systems experience

  • Certified or experienced in Lean Six Sigma or continuous improvement methodology

  • Proven ability to manage ambiguity and multiple initiatives simultaneously

  • Strong communicator with excellent coaching and feedback capabilities

  • Project management skills with experience leading complex initiatives

Additional Details

  • Seniority Level: Mid-Senior

  • Management Experience: Not required, but leadership experience essential

  • Travel: Occasional

  • Visa Sponsorship: Not available

  • Security Clearance: Not required

  • Relocation Assistance: Yes, for the ideal candidate

Take Charge of Change

This role is built for a strategic, hands-on leader who thrives in a fast-paced, quality-first environment. If you're ready to elevate your impact, drive performance, and shape the future of manufacturing—this is your opportunity.