Medical Device Quality Assurance Professional

2 days ago

Cork, Cork, Ireland beBeeQuality Full time €60,000 - €75,000
Quality Assurance Associate

This role involves maintaining our Quality Management System and managing internal processes and external vendors to ensure product quality.

Key Responsibilities:
  • Maintaining the effectiveness of the QMS and making continuous improvements to it.
  • Managing day-to-day QA activities, including frequent interface with contract manufacturers, QA consultants, and testing contractors.
  • Assisting in notified body audits and internal audits.
  • Maintaining and coordinating quality system schedules, including supplier and internal audits, management review, and documentation updates.
  • Supporting the wider team to ensure product manufacture and testing meets requirements.
  • Building and maintaining strong relationships with suppliers, monitoring their performance, and conducting audits to ensure compliance with quality standards.
  • Investigating, analyzing, and resolving product quality problems, including root cause analysis and implementing corrective and preventive actions.
  • Ensuring incoming materials meet required specifications and working with the engineering team to address any quality concerns.
Requirements:
  • Bachelor's degree in engineering or science. Quality certification in ISO 13485 is a must.
  • A minimum of 4 years of experience in a medical device QA position(s) role within a medical device organization.
  • Thorough understanding and knowledge of ISO 13485 and ISO 14971, EU MDR, and 21 CFR Part 820.
  • Desirable to have lead auditor certification and/or regulatory certifications.
  • Proven track record with the ability to successfully manage projects to deadlines.
  • Good documentation practice experience.
  • Report & technical writing experience.
  • Project management experience.
  • Strong ability to manage critical projects as part of an interdisciplinary team.
  • Excellent problem-solving and communication skills.

This is an exciting opportunity for a motivated and detail-oriented individual to contribute to the development of innovative medical devices that simplify surgical procedures.

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