Senior Quality Engineer New

2 weeks ago

Galway, Galway, Ireland CPL Full time
Senior Quality Engineer

Responsibilities:

- Provide Design Assurance support for sustaining commercial projects, ensuring continued compliance with global standards throughout the full product lifecycle.
- Support the implementation of changes to products, processes, or materials within manufacturing by assessing patient risk and maintaining quality standards.
- Provide technical QA input for qualification and validation activities in collaboration with R&D and Manufacturing Engineering.
- Develop and execute Design Verification protocols and compile data for shelf life and regulatory submissions related to design changes.
- Work closely with Regulatory Affairs to ensure clear, accurate, and complete submission materials, minimizing follow-up questions from regulatory agencies.
- Foster strong cross-functional relationships across the organization and external partners in a complex technical environment.
- Lead investigations into quality issues and ensure timely, thorough completion.
- Support continuous improvement by generating and approving change requests and corrective actions.
- Collaborate with engineering and manufacturing to uphold quality standards and drive compliance throughout operations.
- Contribute to the design and specification of inspection and testing equipment; perform quality assurance tests and statistical analysis.
- Ensure that all corrective actions meet required reliability standards and that documentation meets internal and regulatory compliance requirements.

Requirements:

- Expertise in design assurance and quality engineering principles within a regulated industry.
- Experience with qualification and validation processes and risk assessment in support of product and process changes.
- Proficiency in creating and executing Design Verification protocols and preparing regulatory submission documentation.
- Strong knowledge of global regulatory standards related to product design, development, and commercialization.
- Demonstrated ability to work cross-functionally in a technical environment and build collaborative relationships.
- Excellent analytical, problem-solving, and investigation skills.
- Familiarity with statistical analysis, inspection and testing techniques, and quality assurance methods.
- Ability to lead or contribute in specialized areas such as design quality, incoming material inspection, production control, or R&D quality support.

#LI-MS2

  • Senior Quality Engineering Manager

    4 days ago

    Galway, Galway, Ireland beBee Careers Full time

    Senior Quality Engineering ManagerA senior quality engineering manager is required to lead and effectively deliver all quality related aspects of new product introduction, ensuring all customer requirements are identified, documented, understood and met.Key Responsibilities:Lead project teams and ensure the effective delivery of quality related aspects of...

  • Quality Systems Engineer New

    3 weeks ago

    Galway, Galway, Ireland CPL Full time

    Quality Systems EngineerGalway, Ireland | 15 month contractFull-Time£50,000 DOEAre you passionate about medical innovation and driving excellence in quality systems? Join a cutting-edge team in Galway that's shaping the future of implantable medical device coatings. We're on the lookout for a Quality Systems Engineer who will play a key role in ensuring the...

  • Senior Quality Engineer

    2 days ago

    Galway, Galway, Ireland beBee Careers Full time

    Job Title: Senior Design Quality EngineerJob OverviewWe have an exciting opportunity for a Senior Design Quality Engineer to join our team for a full-time, hybrid role on an initial 9-month contract.The ideal candidate will bring extensive experience in quality assurance and compliance, working closely with cross-functional teams to establish customer needs,...

  • Senior Quality Engineer

    4 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 Design Quality Engineer

    3 days ago

    Galway, Galway, Ireland CareerWise Recruitment Full time

    Job Description A SENIOR DESIGN QUALITY ENGINEER is required by CareerWise Recruitment for our multinational medical device client in Galway for a fulltime, hybrid role on an initial 9-month contract. The SENIOR DESIGN QUALITY ENGINEER will provide QA technical and compliance expertise as part of teams tasked with establishing customer needs, developing...

  • Senior Design Quality Engineer

    3 weeks ago

    Galway, Galway, Ireland TN Ireland Full time

    Social network you want to login/join with:Job DescriptionA SENIOR DESIGN QUALITY ENGINEER is required by CareerWise Recruitment for our multinational medical device client in Galway for a fulltime, hybrid role on an initial 9-month contract. The SENIOR DESIGN QUALITY ENGINEER will provide QA technical and compliance expertise as part of teams tasked with...

  • New Product Introduction Engineer

    4 weeks ago

    Galway, Galway, Ireland Pale Blue Dot®Recruitment Limited Full time

    New Product Introduction Engineer (Medical Device)Our Client, a leading Medtech company based in Leitrim, is looking for an NPI Engineer to join their team. Note, a senior position may be considered for a more experienced candidate.Responsibilities include but are not limited to:Leading Projects and Project teams to ensure Project Goals are met, especially...

  • New Product Introduction Engineer

    3 weeks ago

    Galway, Galway, Ireland Pale Blue DotRecruitment Limited Full time

    New Product Introduction Engineer (Medical Device)Our Client, a leading Medtech company based in Leitrim, is looking for an NPI Engineer to join their team. Note, a senior position may be considered for a more experienced candidate.Responsibilities include but are not limited to:Leading Projects and Project teams to ensure Project Goals are met, especially...

  • Senior Quality Design Engineer

    4 weeks ago

    Galway, Galway, Ireland HRM Search Partners Full time

    Senior Quality Design Engineer - Contract (BBBH30500) Galway, Republic of IrelandThis global leader in diagnostics and healthcare technology, renowned for its extensive portfolio of on-market and innovative products, is now on the search for a highly skilled Senior Quality Design Engineer for an initial 12-month contract. As a key player in the medical...

  • Senior Quality Design Engineer

    2 weeks ago

    Galway, Galway, Ireland HRM Search Partners Full time

    Senior Quality Design Engineer - Contract (BBBH30500) Galway, Republic of IrelandThis global leader in diagnostics and healthcare technology, renowned for its extensive portfolio of on-market and innovative products, is now on the search for a highly skilled Senior Quality Design Engineer for an initial 12-month contract. As a key player in the medical...