Senior Quality Assurance Specialist

2 days ago

Cork, Cork, Ireland beBeeQuality Full time €60,000 - €80,000
Job OpportunityQuality Assurance Expert

We are seeking a skilled Quality Assurance Expert to join our dynamic team. As a key member of our quality assurance department, you will be responsible for ensuring the highest standards of product quality.

Key Responsibilities:

  • Maintain and improve the effectiveness of our Quality Management System (QMS).
  • Manage day-to-day QA activities, including interactions with contract manufacturers, QA consultants, and testing contractors.
  • Assist in notified body audits and internal audits.
  • Maintain and coordinate quality system schedules, including supplier and internal audits, management review, and documentation updates.
  • Support the wider team to ensure product manufacture and testing meets required specifications.
  • Build and maintain strong relationships with suppliers, monitoring their performance and conducting audits to ensure compliance with quality standards.
  • Investigate, analyse, and resolve product quality problems, including root cause analysis and implementing corrective and preventive actions.
  • Ensure incoming materials meet required specifications and work with the engineering team to address quality concerns.
  • Maintain Post Market Surveillance activities, including coordinating investigations between complainants and contract manufacturing sites, and follow-up on corrective actions when required.

Requirements:

  • Bachelor's degree in engineering or science.
  • Quality certification in ISO 13485 is mandatory.
  • A minimum of 4 years' experience in a medical device QA position within a medical device organisation.
  • 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.

Why This Role?

This is an exciting opportunity to contribute to the development of innovative medical devices. If you are a motivated and detail-oriented individual with a passion for quality assurance, we encourage you to apply.

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