Senior Manufacturing Quality Engineer

2 weeks ago

Galway, Galway, Ireland SciPro Full time

WHO ARE WE?

A start-up based in Ireland and Germany developing cutting edge innovative imaging technologies to significantly advance healthcare and solve truly global unmet clinical needs. With creativity, passion and focus, we apply our best-in-class engineering and design knowhow to create new hardware, software and data science technologies.

The position, based in Ireland and reporting to the Quality Manager. This position is a hybrid role, with 3 days required on site in Galway. The Senior Manufacturing Quality Engineer is responsible for ensuring that medical device design and development processes comply with applicable regulatory and industry standards, including ISO 13485, ISO 62304, ISO 62366, ISO 60601-1, ISO 60601-2-37, ISO 14971, and medical device labeling requirements. This role will work cross-functionally with R&D, Regulatory Affairs, and Manufacturing to ensure that product design meets both customer needs and regulatory expectations. In addition, this role with support the Quality department in the areas of internal audit, CAPA, non-conformances and document control.

Your role will be

  • Provide quality engineering expertise to support design and development activities in compliance with ISO 13485 and FDA QSR (21 CFR Part 820) requirements.
  • Support risk management activities per ISO 14971, including hazard analysis, FMEA, and risk-benefit analysis.
  • Ensure compliance with software lifecycle processes per ISO 62304, collaborating with software engineering teams to establish and maintain software validation and verification processes.
  • Oversee compliance with usability engineering requirements per ISO 62366, working with human factors specialists and user experience teams.
  • Ensure that electrical and mechanical designs comply with ISO 60601-1 (general safety) and ISO 60601-2-37 (specific requirements for ultrasonic medical devices, if applicable).
  • Support the development and review of medical device labelling, ensuring compliance with international regulations and standards.
  • Lead design reviews and provide quality input throughout product development lifecycle.
  • Develop and execute test method validation (V&V) plans, ensuring compliance with regulatory requirements.
  • Develop and execute design verification and validation (V&V) plans, ensuring compliance with regulatory requirements.
  • Develop and execute computer system validation (V&V) plans, ensuring compliance with regulatory requirements.
  • Support root cause analysis (RCA) and failure mode analysis (FMEA) to identify production issues and implement corrective and preventive actions (CAPA)
  • Collaborate with Regulatory Affairs to support regulatory submissions, providing necessary documentation and justifications.
  • Sit on Change Control Board as Design Quality representative
  • Serve as a quality representative in audits and inspections conducted by regulatory bodies, such as the FDA, ISO auditors, and notified bodies.
  • Ensure compliance with cybersecurity requirements for medical devices in accordance with FDA guidance and EU regulations.
  • Support the integration and validation of Artificial Intelligence (AI) applications in medical devices, ensuring adherence to evolving regulatory expectations and risk management strategies.
  • Support Quality Department in areas of internal audit, CAPA, non-conformances and document control

What you offer

  • Bachelor's degree in Engineering, Quality, or a related field
  • Minimum of 4 years of experience in medical device design quality engineering
  • Strong knowledge of ISO 13485, ISO 62304, ISO 62366, ISO 60601-1, ISO 60601-2-37, ISO 14971, and medical device labeling regulations.
  • Experience working with FDA QSR (21 CFR Part 820) and international regulatory requirements.
  • Proven experience with risk management tools such as FMEA, Fault Tree Analysis, and Hazard Analysis.
  • Hands-on experience with design verification and validation (V&V) processes.
  • Familiarity with product lifecycle management (PLM) systems and document control processes.
  • Strong analytical, problem-solving, and decision-making skills.
  • Ability to influence others and drive quality initiatives across departments, and organizations
  • Excellent communication and teamwork abilities, with experience in cross-functional collaboration.
  • Demonstrated success in driving continuous improvement initiatives
  • Strong project management skills and ability to lead multiple initiatives simultaneously
  • Experience in Internal Audits preferable
  • Willingness to travel up to 25%

WHAT WE OFFER

  • Working on cutting edge imaging systems to the direct benefit of patients and improving healthcare.
  • Becoming part of a dynamic, multi-national team of highly skilled individuals with a very strong focus on team culture and individual development.
  • A learning environment where you can extend and build upon your skills and interests.
  • Flexible working environment and an international culture as well as offices in Germany and Ireland.
#J-18808-Ljbffr

  • Senior Quality Engineer

    3 days ago

    Galway, Galway, Ireland Cregg Group Full time

    About the Role:The Senior Quality Engineer - Manufacturing will be responsible for leading quality assurance protocols and methods for processing materials into finished or semi-finished products. This individual will work effectively as part of a team with shared goals, using data analysis to identify trends and recommend updates or changes to quality...

  • Senior Manufacturing Quality Engineer

    2 weeks ago

    Galway, Galway, Ireland LUMA Vision Ltd. Full time

    Senior Manufacturing Quality Engineer (m/f/d) GalwayLUMA Vision is a start-up based in Dublin (Ireland) and Munich (Germany) developing cutting edge innovative imaging technologies to significantly advance healthcare and solve truly global unmet clinical needs. With creativity, passion and focus, we apply our best-in-class engineering and design knowhow to...

  • Senior Quality Engineer

    2 weeks ago

    Galway, Galway, Ireland Life Science Recruitment Ltd 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 Manufacturing Engineer

    2 weeks ago

    Galway, Galway, Ireland Life Science Recruitment Ltd Full time

    Our client a high potential medical device start up is actively seeking a Senior Manufacturing Engineer to join their expanding engineering team. Reporting to Operations Manager the Senior Manufacturing Engineer will be integral to optimizing, supporting, and advancing manufacturing processes through the application of technical expertise and Lean is an...

  • Senior Manufacturing Engineer

    2 weeks ago

    Galway, Galway, Ireland Life Science Recruitment Ltd Full time

    Our client a high potential medical device start up is actively seeking a Senior Manufacturing Engineer to join their expanding engineering team.Reporting to Operations Manager the Senior Manufacturing Engineer will be integral to optimizing, supporting, and advancing manufacturing processes through the application of technical expertise and Lean is an...

  • Senior Manufacturing Engineer

    2 weeks ago

    Galway, Galway, Ireland Life Science Recruitment Full time

    Our client, a high potential medical device start-up, is actively seeking a Senior Manufacturing Engineer to join their expanding engineering team. Reporting to the Operations Manager, the Senior Manufacturing Engineer will be integral to optimizing, supporting, and advancing manufacturing processes through the application of technical expertise and Lean...

  • Senior Manufacturing Engineer

    2 weeks ago

    Galway, Galway, Ireland Life Science Recruitment Full time

    Our client, a high potential medical device start-up, is actively seeking a Senior Manufacturing Engineer to join their expanding engineering team. Reporting to the Operations Manager, the Senior Manufacturing Engineer will be integral to optimizing, supporting, and advancing manufacturing processes through the application of technical expertise and Lean...

  • Senior Manufacturing Engineer

    2 weeks ago

    Galway, Galway, Ireland Cregg Group Full time

    Senior Process Development Engineer CREGG are seeking experienced Process Development Engineers to join our Galway-based multinational medical device manufacturer. Engineers with strong Manufacturing/Process Development experience encouraged to apply. To discuss this role please call Rachel / About the role: Hours of work :39 hr week with a 1pm Friday...

  • Senior Manufacturing Engineer

    1 day ago

    Galway, Galway, Ireland Sterling Engineering Ltd - Ireland & Europe Full time

    Recruitment Consultant at Sterling Engineering Ltd - Ireland & EuropeJob Summary:Our Client is seeking a detail-oriented and experienced Senior Manufacturing Engineer to lead and optimize manufacturing processes for their medical device products. This role is critical in ensuring efficient production, compliance with regulatory standards, and continuous...

  • Senior Manufacturing Engineer

    2 weeks ago

    Galway, Galway, Ireland Cregg Group Full time

    Senior Process Development Engineer CREGG are seeking experienced Process Development Engineers to join our Galway-based multinational medical device manufacturer.Engineers with strong Manufacturing/Process Development experience encouraged to apply.To discuss this role please call Rachel / About the role: Hours of work :39 hr week with a 1pm Friday...

  • Manufacturing Quality Engineer

    2 weeks ago

    Galway, Galway, Ireland SPEEDECK Full time

    Key Highlights">As a Quality Engineer at Mbryonics, you will have the opportunity to:Develop and implement quality control systems to ensure the highest standards for our products and processes.Collaborate with cross-functional teams to drive continuous improvement and innovation.Work with talented professionals across disciplines to develop impactful...

  • Senior Manufacturing Engineer

    7 hours ago

    Galway, Galway, Ireland Collins McNicholas Recruitment Full time

    Our client, multinational medical device company is seeking a Senior Manufacturing Engineer to join their team in Galway on a 12 month fixed term contract.Responsibilities:1. Design manufacturing processes, procedures, and production layouts for assemblies, equipment installation, processing, machining, and material handling.2. Plan machine arrangements...

  • Manufacturing Quality Engineer

    1 week ago

    Galway, Galway, Ireland MSA, The Safety Company Full time

    Job Summary:We are seeking an experienced Manufacturing Quality Engineer to join our team at MSA, The Safety Company.The successful candidate will have a proven track record of delivering quality and compliance in a fast-paced manufacturing environment, with a strong focus on process improvement and customer satisfaction.Main Responsibilities:Monitor...

  • Manufacturing Engineer

    3 weeks ago

    Galway, Galway, Ireland NES Fircroft Full time

    Direct message the job poster from NES FircroftSupporting CAPEX and OPEX projects within the Life Science Industry.Manufacturing Engineer – 12 months - Contract – Hybrid role (3 days onsite/week)As a Manufacturing Engineer, you will support manufacturing processes and equipment to ensure efficient production.Key Responsibilities:Process optimization to...

  • Senior Manufacturing Engineer

    1 week ago

    Galway, Galway, Ireland Sigmar Recruitment Full time

    Job description Senior Manufacturing Engineer About Your New Employer With more than three decades of global leadership in the medical devices industry, our mission is to transform the lives of patients worldwide by advancing science. We'll help you in strengthening your skills as a Production Supervisor with access to the latest tools, information...

  • Manufacturing Engineer

    1 day ago

    Galway, Galway, Ireland CREGG Full time

    C REGG is currently seeking a highly skilled and motivated Manufacturing Engineer - Quality to join their team in Athenry, Co. Galway.About the RoleThis exciting opportunity allows you to contribute to quality improvement initiatives in a fast-paced and innovative environment.The ideal candidate will have experience in implementing lean practices in QMS...

  • Senior Quality Engineer

    3 weeks ago

    Galway, Galway, Ireland TN Ireland Full time

    Social network you want to login/join with:Senior Quality Engineer (Aortic)Client: MedtronicLocation: Galway, IrelandJob Category: OtherEU work permit required: YesJob Reference: 4682a8565612Job Views: 2Posted: 28.03.2025Expiry Date: 12.05.2025Job DescriptionMedtronicAt Medtronic, we value what makes you unique. Be part of a company that thinks differently...

  • Senior Quality Engineer

    3 weeks ago

    Galway, Galway, Ireland Cpl Healthcare Full time

    Senior Quality EngineerTo provide QA technical and compliance expertise as part of teams tasked with establishing customer needs, developing new products and/or modifying existing designs. Assure compliance to applicable regulations and lead quality activities such as risk assessments, device testing, audits, procedure development, documentation review and...

  • Senior QA Engineer

    7 days ago

    Galway, Galway, Ireland CareerWise Recruitment Full time

    We are looking for a Senior QA Engineer - Manufacturing to join our Mayo based manufacturing client. The successful candidate will have experience in managing audits, training in the compliance of SOPs.The Job Summary:Work collaboratively with the commercial and technical operations teams to deliver QA objectives and drive business growth.Develop and track...

  • Manufacturing Engineer

    3 weeks ago

    Galway, Galway, Ireland Sterling Engineering Ltd - Ireland & Europe Full time

    Position: Manufacturing EngineerLocation: GalwaySalary: €55,000+ packageOur Client is a Global Leader in the Med Device Manufacturing Sector and now requires a Manufacturing Engineer on a full-time basis.Responsibilities:Develop innovative solutions to complex engineering and manufacturing production problems.Design and develop tools and equipment,...