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.