Chief Quality Assurance Specialist

2 weeks ago

Galway, Galway, Ireland beBeeQuality Full time €75,000 - €90,000

Senior Quality Systems Engineer

This role offers a unique opportunity to work as a Senior Quality Systems Engineer in the medical device industry.

  • Ensure quality systems are compliant with Medical Device Directives and Regulations, including FDA Quality System Regulations.
  • Maintain and improve quality management systems.
  • Coordinate CAPA, Complaints & Temporary Authorization processes.
  • Review and approve Non-conformance, CAPA and Complaint investigation reports.
  • Manage audit schedules and coordinate internal and external audits.
  • Track audit actions from initiation to closure.

Responsibilities:

As a Senior Quality Systems Engineer, you will play a key role in establishing, implementing, and maintaining high-quality standards. You will work closely with the team to ensure compliance with regulatory requirements and maintain quality excellence.

Requirements:

To be successful in this role, you should have a Diploma Level in an Engineering, Science or Quality Assurance discipline and a minimum of five years' relevant experience in the medical device industry. Familiarity with ISO 13485, ISO 14971 and Medical Device Regulation is required.

About This Role

The ideal candidate will possess excellent problem-solving skills, strong analytical thinking, and effective communication skills. A collaborative approach and ability to work well in a team environment is essential for success in this position.

Benefits of Working With Us

We offer a dynamic and supportive work environment that encourages growth and development. Our team is dedicated to delivering exceptional results and making a positive impact in the industry.

  • Quality Assurance Specialist

    2 weeks ago

    Galway, Galway, Ireland beBeeQuality Full time €70,000 - €85,000

    Job Title: Quality Assurance SpecialistWe are seeking a skilled Quality Assurance Specialist to review and approve critical documents, provide quality support on the shop floor, and drive quality initiatives.

  • Quality Assurance Specialist

    2 weeks ago

    Galway, Galway, Ireland beBeeRegulatory Full time €80,000 - €120,000

    Job TitleQuality Assurance Specialist - GalwayOur team is seeking an experienced Quality Assurance Specialist to provide quality support for site activities, ensuring compliance with standards and collaborating with cross-functional teams. The ideal candidate will have experience in quality assurance and the ability to communicate effectively.The successful...

  • Senior Quality Assurance Specialist

    2 weeks ago

    Galway, Galway, Ireland beBeeQuality Full time €80,000 - €100,000

    Job Title:Senior Quality Assurance SpecialistWe are seeking an experienced Senior Quality Assurance Specialist to play a key role in the implementation and maintenance of our quality management systems.Key Responsibilities:Ensure that all quality systems are compliant with relevant regulations, including Medical Device Directive 93/42/EEC, Medical Device...

  • Quality Assurance Professional

    2 hours ago

    Galway, Galway, Ireland beBeeAssurance Full time €55,000 - €70,000

    Quality Assurance SpecialistWe are seeking an experienced Quality Assurance Specialist to join our team in Galway. The ideal candidate will have a strong background in quality management and be able to work effectively in a production environment.Responsibilities:Monitor compliance with quality standards and procedures, providing coaching and training as...

  • Senior Quality Assurance Specialist

    2 weeks ago

    Galway, Galway, Ireland beBeeQuality Full time €80,000 - €100,000

    The Plant Senior Quality Assurance Specialist will drive supplier process and systemic quality improvements. This position is the enabler of effective execution of Advanced Product Quality Planning through the receipt, release, and delivery of components to the manufacturing line.ResponsibilitiesLead project teams related to incoming quality issues, CAPA,...

  • Medical Device Quality Assurance Specialist

    12 hours ago

    Galway, Galway, Ireland beBeeQuality Full time €63,000 - €93,000

    Job Description:We are seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring the quality and compliance of our medical devices. Your primary objective will be to identify and mitigate potential quality risks, ensuring that our products meet the highest standards of...

  • Senior Quality Assurance Specialist

    3 weeks ago

    Galway, Galway, Ireland Soti Inc Full time

    Senior Quality Assurance Specialist page is loadedSenior Quality Assurance SpecialistApply locations Galway, Ireland time type Full time posted on Posted 3 Days Ago job requisition id R08980SOTI is committed to providing its employees with endless possibilities; learning new things, working with the latest technologies and making a difference in the...

  • Senior Quality Assurance Specialist

    3 weeks ago

    Galway, Galway, Ireland SOTI Inc Full time

    Senior Quality Assurance Specialist page is loadedSenior Quality Assurance SpecialistApply locations Galway, Ireland time type Full time posted on Posted 3 Days Ago job requisition id R08980SOTI is committed to providing its employees with endless possibilities; learning new things, working with the latest technologies and making a difference in the...

  • Software Quality Assurance Specialist

    17 hours ago

    Galway, Galway, Ireland beBeeQuality Full time €80,000 - €150,000

    Job Description">This role offers an exciting opportunity to work with a market leading organisation during an exciting time of growth and expansion. As a Contract Software Quality Assurance Specialist, you will be responsible for creating test cases to identify areas that require improvement in line with the test plan.">Responsibilities">">Create test cases...

  • Quality Assurance Specialist

    2 weeks ago

    Galway, Galway, Ireland beBeeQuality Full time €50,000 - €75,000

    Discover Your Future in Quality AssuranceJob OpportunityWe are seeking a diligent Quality Assurance professional to join our team.Evaluate complex product exceptions and develop effective solutions.Make informed decisions regarding product quality, including the disposition of non-conforming products.Promote excellence in product and process quality through...