Expert Design Assurance Specialist

8 hours ago

Galway, Galway, Ireland beBeeDesignAssurance Full time €80,000 - €105,000

Design Assurance Expert

  • A leading medical device company seeks an experienced Design Assurance Specialist to lead their Quality Assurance/Regulatory Affairs team. The ideal candidate will be responsible for Medical Product (CE Mark and FDA 510k) Design Assurance, Design Controls, Product and Process Validation System, and Risk Management Activities.
  • The successful individual will perform technical reviews of design documentation and labelling, attend design reviews, coordinate completion and update of design risk management documentation, and act as independent reviewer for all design activities including design changes.
  • They will also project manage EU MDR deliverables and support MDR projects as needed by the QARA Department.
  • Quality approval of relevant records, tests, validations, reports, and project file entries is also a key responsibility.
  • The role requires strong communication skills to promote awareness of regulatory and customer requirements throughout the organization.
  • Standards gap analyses for MDR and R&D projects will be conducted, and the individual will provide guidance and training for new hires and student engineers.
  • They will support test development and method validation, lead data analysis best practice, and implement updates to applicable quality system requirements.
  • A systematic review approach and ability to initiate and lead change and continuous improvement are essential qualities.

Requirements:

  • Bachelor's degree in Engineering, Technology, or Science.
  • At least 5-7 years' experience working in a regulated device or pharmaceutical company.
  • Excellent planning and coordination skills.
  • Strong verbal and written communication skills.
  • Attention to detail is crucial for this Quality role.
  • Training in risk management, problem-solving methods, design controls, validations, usability, or biocompatibility would be beneficial.

About This Role:

This is a fantastic opportunity for an experienced professional to join a dynamic team and contribute to the development of high-quality medical devices.

  • Design Assurance Specialist

    15 hours ago

    Galway, Galway, Ireland beBeeQuality Full time €63,000 - €84,000

    Job Title: Design Assurance SpecialistWe are seeking a highly skilled individual to fill the role of Design Assurance Specialist.Key Responsibilities:Design control experience with end-to-end involvement2+ years of experience in regulated industry environmentUnderstanding of user requirements and how to translate these through design outputs and verification...

  • Senior Medical Device Design Assurance Specialist

    5 days ago

    Galway, Galway, Ireland beBeeQuality Full time €60,000 - €80,000

    Design Assurance ExpertThe Design Assurance Expert will be responsible for ensuring the quality and safety of medical device products.

  • Automation Expert for Quality Assurance

    2 days ago

    Galway, Galway, Ireland beBeeAutomation Full time €48,000 - €96,000

    Test Automation SpecialistWe are seeking an accomplished Automation Expert to spearhead quality assurance efforts. This role offers a unique opportunity to collaborate with industry leaders during a period of rapid growth and transformation.This position involves developing automated test cases to identify areas for improvement, designing a comprehensive...

  • Quality Assurance Specialist

    3 days ago

    Galway, Galway, Ireland beBeeQuality Full time €60,000 - €80,000

    Job Title: Quality Assurance SpecialistWe are seeking a highly experienced and skilled Quality Assurance Specialist to play a key role in ensuring product quality during early development phases through to commercial.About the Role:Lead compliance and improvement activities associated with the quality system (e.g. CAPA, audit programs, personnel...

  • Senior Design Assurance Specialist

    15 hours ago

    Galway, Galway, Ireland beBeeQuality Full time €80,000 - €110,000

    Job TitleDesign Assurance Program ManagerResponsibilitiesLead Quality Representative on projects, contributing and/or providing guidance to establish appropriate Design History File / Device Master Record documentation.Ensure project teams utilize quality systems and appropriate regulations and industry standards throughout the product development...

  • Design Assurance Engineer

    3 weeks ago

    Galway, Galway, Ireland Actalent Full time

    We are seeking a highly motivated and experienced Design Assurance Engineer to join a Medical device company in Galway. This role involves supporting the lifecycle of medical device products, managing design changes, ensuring compliance with risk management and design control requirements, and supporting complaint investigations to ensure safety and...

  • Senior Quality Assurance Specialist

    3 days ago

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

    Senior Quality Assurance SpecialistWe are seeking a highly skilled Senior Quality Assurance Specialist to join our Receiving Inspection Department. The ideal candidate will have a strong background in quality assurance, inspection methods, and process improvements.Main Responsibilities:Evaluate inspection processes and develop effective solutionsCreate and...

  • Quality Assurance Expert

    3 days ago

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

    Job Title: Quality Assurance ExpertOur organization is seeking a Quality Assurance Expert to oversee quality systems, internal manufacturing processes, and supplier relationships.This role will report directly to the Chief Operating Officer (COO) and be responsible for maintaining the company's Quality Management System (QMS), supervising quality...

  • Senior Technical Assurance Specialist

    15 hours ago

    Galway, Galway, Ireland beBeeTechnical Full time €90,000 - €120,000

    Senior Technical Assurance SpecialistThe ideal candidate will possess a strong background in technical assurance and have experience working with various regulations, including ISO 13485 and FDA Quality System Regulations.Key Responsibilities:Ensure compliance with relevant regulatory requirements and industry standards by developing and implementing...

  • Design Assurance Quality Lead

    5 days ago

    Galway, Galway, Ireland beBeeQuality Full time

    Job Title: Design Assurance Quality LeadAbout the RoleWe are seeking a seasoned quality assurance professional to lead our design assurance program. In this role, you will be responsible for ensuring that all design activities meet the required standards and regulatory requirements.Key ResponsibilitiesLead quality representative on projects, contributing to...