Quality Management Systems

Quality Assurance Regional Manager โ€“ Albert Lea, MN

Quality Assurance Regional Manager

๐Ÿ“ Location: Albert Lea, Minnesota (Oversight of Multiple Manufacturing Sites)
๐Ÿ’ผ Employment Type: Full-Time
๐Ÿ’ฐ Base Salary: $130,000 โ€“ $145,000
๐Ÿšš Relocation Assistance: Available for Ideal Candidates
โœˆ๏ธ Travel: Frequent Regional Travel Required
๐Ÿšซ 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

โœ” Quality Assurance Leadership
โœ” FDA Compliance
โœ” HACCP & SQF Programs
โœ” Food Safety Systems
โœ” CAPA Management
โœ” Root Cause Analysis
โœ” Internal Auditing
โœ” SPC & Data Analysis
โœ” Team Development
โœ” 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 โ€“ Medical Devices | Limerick, IRE

Senior Software Quality Engineer

๐Ÿ“ Location: Limerick, Ireland
๐Ÿข Work Model: Hybrid โ€“ Minimum 4 days onsite
๐Ÿ’ผ Employment Type: Full-Time
๐Ÿ’ฐ Salary: โ‚ฌ60,000 โ€“ โ‚ฌ70,000
โœˆ๏ธ Travel: Occasional
๐ŸŽ“ Education: Bachelorโ€™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

  • Bachelorโ€™s degree in:

    • Software Engineering

    • Electrical Engineering

    • Biomedical Engineering

    • Mechanical Engineering

    • Or a related technical discipline

  • 6โ€“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 โ€“ Design Assurance | Medical Devices | Limerick, Ireland

Senior Quality Engineer โ€“ Design Assurance

๐Ÿ“ Location: Limerick, Ireland
๐Ÿข Work Model: Hybrid โ€“ Minimum 4 days onsite
๐Ÿ’ผ Employment Type: Full-Time
๐Ÿ’ฐ Salary: โ‚ฌ60,000 โ€“ โ‚ฌ70,000
โœˆ๏ธ Travel: Occasional
๐ŸŽ“ Education: Bachelorโ€™s Degree in Engineering or related discipline preferred

Role Overview

A global medical technology organization is seeking a Senior Quality Engineer โ€“ 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 lifecycleโ€”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

  • Bachelorโ€™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 โ€“ Supplier Quality & Process Improvement (On-site, San Diego)

โš™๏ธ Supplier Technical Engineer

๐Ÿ“ Location: San Diego, CA (On-site)
๐Ÿ’ผ Employment Type: Full-Time
๐Ÿญ Industry: Energy
๐Ÿ“ฆ Function: Supply Chain / Supplier Quality
๐Ÿ›‚ Visa Sponsorship: Not available
๐ŸŽฏ Level: Associate (2โ€“5 yearsโ€™ experience)

๐ŸŒŸ 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.

๐Ÿ”ง 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

๐Ÿง  Core Competencies Youโ€™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

๐ŸŽ“ Background & Experience

Required

  • Bachelorโ€™s degree in Supply Chain, Engineering, or related field

  • 2โ€“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

๐Ÿ’ฐ Compensation & Benefits

  • Salary Range: $89,210 โ€“ $133,810

  • Benefits: Full benefits package

  • Bonus: Not eligible

  • Relocation: Not available

  • Travel: None required