Quality Assurance Manager

2 weeks ago

Galway, Ireland John Madden & Assoc Full time

Our client, a new 'start up' medical device company based in Galway is seeking an ambitious and energetic individual for the following position with responsibility for the implementation and operation of the Company Quality Management System:Quality Assurance ManagerReporting to the Chief Executive Officer, this role is responsible for establishing the Company's quality assurance plan and ensures that the company operates under an approved Quality Management System that meets both regulatory and operational requirements.The Quality Manager plays a key role in developing the Company's strategy in determining and negotiating with regulatory bodies regarding its service offering to various customers.Primary Responsibilities:· Develop the Quality Management System (QMS) to FDA / CE compliance standards and interface with notified bodies to properly manage, plan and pass regulatory and quality audits to achieve and maintain the company's ISO ***** certification.· Advise R&D and Manufacturing on the regulatory impact of material selection, product design, manufacturing processes, product classification and the regulatory/product approval impact of specific customer product design revisions.· Keep abreast of all new regulatory and quality guidelines and approval requirements for competitive technologies or "similar" risk products in the Company's area of focus and provide leadership on introducing technological advances and devices to Ireland.· Interface with equivalent functions within our customer's organisations to ensure alignment regarding the quality and regulatory requirements of the various customer's products under development and/or manufacture.· Engage with the Management Team on a regular basis to review the scope of the company's ISO certification and amend as required via the appropriate engagement with the relevant Notified Body.The Successful Candidate will possess:· An appropriate third level qualification with a minimum of 10 years' experience in the quality field at senior quality engineering or manager level having responsibility for CE market approval.· Demonstrated ability for establishing and maintaining a Quality Management System having prepared for and passed quality inspections from a recognised Notified Body.· Experienced project management skills and the ability to develop and execute a plan to achieve CE Mark.· Risk management skills and experience in working with medical device engineers on how to set up and document the design and development process to ensure all work completed is documented and valid to support design and development and ultimately transfer to manufacture.Benefits include a highly competitive remuneration package, including participation in the Company Share Option, Healthcare Insurance, Bonus and Pension scheme.Applications please, or call for further information in strict confidence, by the 29thAugust **** to:John Madden FCIPD Tel.No.:E-mail: or

  • Quality Assurance Project Manager

    2 weeks ago

    Galway, Ireland 360 Technology Full time

    Position:Business Project Manager – QA (Regulatory & Digital Transformation)Location:Athenry, Ireland and HybridExperience:8+ years (with strong QA/Regulatory project management background)Domain:Medical Device / Life Sciences / Regulated ManufacturingJob Summary:We are seeking aBusiness Project Manager (QA – Regulatory)to lead initiatives focused on...

  • Quality Assurance Engineer

    2 weeks ago

    Galway, Ireland Surmodics, Inc. Full time

    Title:Quality Assurance EngineerReport To:Staff Quality EngineerLocation:Ballinasloe, Co.GalwayPermanent RoleOnsite Role,Days of Work:Monday to Thursday (4 Day Work Week)Ready to make a difference by utilizing your talents?Join a team driven by a mission to help patients, and a culture focused on developing medical devices and diagnostic solutions.Surmodics...

  • Design Quality Assurance 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,...

  • Director Of Quality Assurance

    2 weeks ago

    Galway, Ireland Scipro Full time

    Director of Quality & Regulatory AffairsAre you passionate about driving excellence in quality systems and regulatory compliance?This senior leadership role offers the opportunity to oversee and shape global quality and regulatory operations for an organization developing innovative medical technologies.About the RoleAs Director of Quality & Regulatory...

  • Senior Design Assurance Manager

    2 weeks ago

    Galway, Ireland Boston Scientific Full time

    Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt 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 training,...

  • Senior Design Assurance Manager

    3 weeks ago

    Galway, Ireland Boston Scientific Gruppe Full time

    Press Tab to Move to Skip to Content LinkSelect how often (in days) to receive an alert: Create AlertDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt 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...

  • Quality Systems Manager

    4 weeks ago

    Galway, Ireland TE Connectivity Full time

    Social network you want to login/join with: At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world. Contract Type 12 Month Fixed Term Contract Job Overview The Quality System Manager is responsible for managing the processes and people within the Quality...

  • Quality Assurance Engineer

    2 weeks ago

    Galway, Ireland Msa - The Safety Company Full time

    OverviewAre you someone who is passionate, motivated, and driven to make a difference?If so, MSA Safety is the perfect fit for your career.At MSA, SAFETY is who we are AND it is what we do.We are a purpose-driven company committed to deploying innovation and technology to deliver on our Mission to help protect people and assets all around the world.We...

  • Sterility Assurance Lead

    2 weeks ago

    Galway, Ireland Viatris Full time

    Mylan TeorantaAt VIATRIS, we see healthcare not as it is but as it should be.We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.Viatris empowers people worldwide to live healthier at every stage of life.We do so via:Access – Providing high quality trusted medicines regardless of geography or...

  • Quality Assurance Engineer

    2 weeks ago

    Galway, Ireland Msa Safety Full time

    ****QualityOnsiteBallybrit Galway, IrelandJob DescriptionOverviewAre you someone who is passionate, motivated, and driven to make a difference?If so, MSA Safety is the perfect fit for your career.At MSA, SAFETY is who we are AND it is what we do.We are a purpose-driven company committed to deploying innovation and technology to deliver on our Mission to help...