Quality Engineering

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

 

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

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⚙️ 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

 

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