Medical Device Quality Assurance Role

4 days ago

Dublin, Dublin City, Ireland beBeeQuality Full time €80,000 - €100,000
Quality Assurance Specialist

This role involves driving the day-to-day implementation of the quality management system, with a focus on continuous improvement. The successful candidate will work closely with manufacturing, supply chain, and design assurance teams to ensure that all necessary QA activities are planned, executed, and documented.

Responsibilities:
  • Develop and implement QMS processes and procedures
  • Lead QMS continuous improvement activities
  • Ensure delivery of overall quality strategy and support achievement of business quality objectives
  • Collaborate with wider team to ensure necessary QA activities are planned, executed, and documented
  • Interpret relevant standards and ensure company meets requirements
  • Develop and review test specifications, part specifications, and design specifications with cross-functional team
  • Support manufacturing team activities associated with manufacturing in a regulated environment, e.g., equipment qualification, process validation, and change control
  • Provide practical QA and Design Assurance expertise
  • Support supply chain in supplier-related activities, e.g., process development and manufacturing requirements
  • Coordinate and manage key activities such as internal audit program, material review board, NC/CAPA review board, complaint process
  • Project support for regulatory submissions
  • Support clinical investigations
Qualifications:
  • Bachelor's Degree in Engineering, Science, or related field
  • 3+ years' experience in medical device quality/design assurance role
  • Recent regulatory experience including FDA regulations, ISO 13485, Medical Device Directive, and other applicable national and international regulations and standards

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