Senior Quality Engineer

4 weeks ago

Galway, Ireland Life Science Recruitment Ltd Full time

Senior Quality Engineer (Operations & Compliance Lead) Join an innovative, growing Medical Device company based in Galway, focused on pioneering solutions that are changing patient lives in the healthcare sector. We operate a proactive Quality Assurance department that is integral to our Operations team and drives compliance and continuous improvement throughout our manufacturing and supplier are seeking a proactive and detail-oriented Senior Quality Engineer to act as a technical and quality champion for our Operations team. This role is a key leadership position focused on managing and improving the QMS, leading complex quality projects, and ensuring robust supplier qualification. If you have a passion for driving systemic improvement and want a pathway to management responsibility, this is the ideal next step. Key Responsibilities Continuous Improvement & CAPA: Champion continuous improvement initiatives, driving the CAPA system and analyzing key Quality KPI's to reduce variation and improve performance. Quality Leadership: Support and mentor junior Quality Engineers and Technicians, assigning tasks, coordinating workload, and providing technical instruction and feedback. Validation & Documentation: Review and approve crucial documentation, including Validation protocols and reports (IQ, OQ, PQ), and engineering changes. Audits & Compliance: Lead and participate in internal and external audits to ISO 13485 and FDA requirements, and support Notified Body and Regulatory Agency inspections. Supplier Qualification: Lead Supplier Management and Qualification activities, including maintaining the Approved Supplier List (ASL), qualifying new vendors through audits and assessments, and monitoring supplier performance via scorecards. Cross-Functional Support: Act as the Quality Assurance representative on Design Projects supporting new product introductions, and ensure GMP standards are upheld across all areas (Operations and Supply Chain). Risk Management: Actively participate in and/or lead Risk Analysis initiatives (e.g., FMEA) and root cause analysis investigations. Candidate Profile Education: Level 8 Degree (or equivalent) in Science, Engineering, Quality Engineering, or a similar technical field. Experience: Minimum 5 years relevant experience within the Medical Device industry is essential. QMS & Regulatory: Clear understanding and practical experience with FDA QSR (21CFR Part 820) and ISO 13485 Quality Systems. Core Technical Skills: Significant experience with test method and process validation activities is a must. Problem Solving: Proven experience in root cause analysis and CAPA methodologies. Organizational: Excellent organizational skills and the ability to work effectively on own initiative are essential. Advantageous: Experience in people management or demonstrated mentorship experience is highly desirable. Interested in leading high-impact Quality projects in Galway? Apply in confidence today or contact James Cassidy for more details.

  • Senior Quality Engineer

    7 days ago

    Galway, Ireland Life Science Recruitment Full time

    Senior Quality Engineer Our client a medical device startup company is seeking a Senior Quality Engineer to join their team. Reporting to the Senior Quality Manager the Senior Quality Engineer will work across all stages of development, manufacture, and commercialisation. The candidate will support the Senior Quality Manager with maintaining the Quality...

  • Senior Quality Engineer

    3 weeks ago

    Galway, Ireland Sterling Engineering Full time

    Senior Quality Engineer Location: Galway, Ireland (Hybrid) Department: Operations Type: Full-time, Permanent Role Overview The Senior Quality Engineer will lead operations quality activities to support the commercialisation and manufacturing scale-up of a new electro-mechanical medical device. The role ensures full compliance with regulatory standards while...

  • Senior Supplier Quality Engineering Supervisor

    3 weeks ago

    Galway, Ireland Medtronic Full time

    Senior Supplier Quality Engineering Supervisor Join to apply for the Senior Supplier Quality Engineering Supervisor role at Medtronic . At Medtronic, you can begin a life‑long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more...

  • Senior Quality Engineer

    4 weeks ago

    Galway, Ireland PlaceMe Recruitment Full time

    Overview The successful candidate will have overall ownership, accountability and responsibility for the management of all Quality related activity on all of the Value streams in the Galway Plant, and management of the Line engineering function. The focus will be on implementing a robust preventative Quality program across all associated value stream...

  • Senior Supplier Quality Engineering Supervisor

    4 weeks ago

    Galway, Ireland Medtronic Vascular Galway UC Full time

    At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Medtronic At Medtronic, we value what makes you unique. Be part of a company that thinks...

  • Senior Quality Engineer, Medical Devices

    2 weeks ago

    Galway, Ireland CREGG Full time

    A leading multinational medical device manufacturer in Galway is seeking a Senior Quality Engineer. The role involves supporting product lifecycle compliance, generating Design Verification protocols, and ensuring adherence to regulatory standards. The ideal candidate has a Bachelor’s degree and 5-8 years’ experience in QA within the medical devices...

  • Quality Engineer

    3 weeks ago

    Galway, Ireland Quasarmedical Full time

    To ensure that products and manufacturing processes comply with all relevant quality, regulatory, and industry standards. This role will support and enhance the Quality Management System (QMS), ensuring adherence to regulations such as FDA, ISO, and other applicable standards. The Quality Engineer will collaborate with cross-functional teams to identify and...

  • Quality Engineer

    3 weeks ago

    Galway, Ireland Reperio Human Capital Ltd Full time

    Quality Engineer - Contract I'm looking for a proactive individual to work with my reputable client on an upcoming project on a daily rate contract basis. This role will initially be for 6 months but will like offer further extension. Its an excellent opportunity for an experienced quality engineer who is looking for their next role and can support an...

  • Senior Supplier Quality Manager II

    3 weeks ago

    Galway, Ireland Boston Scientific Gruppe Full time

    Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and...

  • Quality Engineer II

    4 weeks ago

    Galway, Ireland Boston Scientific Gruppe Full time

    Overview Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools,...