Senior Quality Engineer

3 hours 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

    1 week ago

    Galway, Ireland Sterling Engineering Full time

    Senior Quality Engineer Overview We are seeking an experienced Senior Quality Engineer to lead digital quality initiatives and support the integration of automated, data-driven processes across manufacturing and quality systems. This role will ensure regulatory compliance (FDA, EU MDR, ISO 13485) and drive continuous improvement of digital workflows, MES,...

  • Senior Quality Engineer

    2 weeks ago

    Galway, Ireland CREGG Full time

    Exciting opportunity for a Senior Quality Engineer to join Galway’s leading multinational medical device manufacturer. Job Description: - Support sustaining commercial projects from a Design Assurance perspective. You will be directly involved in making sure products are maintained through the full product lifecycle and that these products comply with...

  • Senior Quality Engineer

    4 hours 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 Quality Engineer

    4 weeks ago

    Galway, Ireland Ama Consulting Group Llc Full time

    Role:Senior Quality Engineer (Operations)Location:Neurent Medical Ltd., GalwayDepartment:Quality AssuranceReporting:Quality ManagerDUTIES AND RESPONSIBILITIES:Support and mentor Quality engineers and technicians.Assign tasks, coordinate and provide instruction and feedback as required.Champion continuous improvement through CAPA system, analyzing key...

  • (Only 24h Left) SENIOR QUALITY ENGINEER

    4 weeks ago

    Galway, Ireland AMA Consulting Group LLC Full time

    Role: Senior Quality Engineer (Operations) Location: Neurent Medical Ltd., Galway Department: Quality Assurance Reporting: Quality Manager DUTIES AND RESPONSIBILITIES: - Support and mentor Quality engineers and technicians. Assign tasks, coordinate and provide instruction and feedback as required. - Champion continuous improvement through CAPA system,...

  • Quality Engineer

    6 days ago

    Galway, Ireland Cpl Full time

    Quality Engineer – Galway (4-Day Work Week!)Looking for your next career move in the medical device sector? This is an exciting opportunity to join a leading organization developing cutting-edge medical devices and diagnostic solutions that truly make a difference in patients’ lives.Why apply?Enjoy a competitive salary and benefits package, including...

  • Senior Engineer

    6 days ago

    Galway, Ireland CSR Group Full time

    Senior Engineer Galway CSR is looking for an experienced Senior Site Engineer to work on a large Residential project in Galway. The company is one of Ireland's leading main contractors over the last 60 years who specialise in all aspects of the Construction Industry. They pride themselves on delivering high quality projects on time and within budget. Due to...

  • Senior Engineer

    6 days ago

    Galway, Ireland CSR Group Full time

    Senior Engineer Galway Sector: Residential | Commercial | Industrial Company: Leading Main Contractor Location: Galway, Ireland Employment Type: Full-Time, Permanent Salary: €70-80k + Benefits Package Build Your Career with a Leading Main Contractor Our client, a well-established and highly regarded main contractor with a strong presence across the west of...

  • Quality Engineer New

    3 weeks ago

    Galway, Ireland CPL Full time

    Quality Engineer Summary: The Quality Engineer ensures that products and materials meet established quality standards throughout the product lifecycle. This role collaborates with engineering, manufacturing, and inspection teams to maintain compliance with regulatory and design control requirements. Responsibilities: - Apply and maintain quality...

  • Quality Engineer

    2 days ago

    Galway, Ireland Reperio Human Capital Full time

    Quality Engineer (contract) 180252 Desired skills: qa engineer, manual tester, software tester, functional tester Reperio has partnered with a reputable organisation that is seeking a proactive Quality Engineer to join an upcoming project on a daily rate contract basis.This initial 6-month contract offers the potential for extension and is an excellent...