Senior Quality Assurance Specialist

4 days ago

Galway, Galway, Ireland beBeeQuality Full time €100,000 - €120,000

We are seeking a seasoned professional to fill the role of Senior Quality Assurance Specialist. The ideal candidate will have a proven track record in ensuring product quality and compliance with regulatory requirements.

The Opportunity

This is an exceptional opportunity for a quality expert to join our team and contribute to the development of innovative medical devices. The successful candidate will play a key role in ensuring product quality, developing and supporting quality management systems, batch release, internal audits, and supplier management.

Responsibilities
  • Evaluate and ensure compliance with policies, procedures, and applicable national and international regulations.
  • Develop and implement control plans, inspection plans, and testing strategies to guarantee product compliance.
  • Collaborate with suppliers to establish robust quality agreements.
  • Support internal teams in product development and gather data to inform statistical rational sample testing requirements.
  • Maintain records of inspections, testing, and non-conformance reports.
  • Analyze and report key data related to product testing, supplier performance, and internal quality metrics.
Requirements
  • A degree in quality engineering, life science, or a related field.
  • 3-5 years of experience in a quality assurance role in the medical device sector, preferably in an FDA/MDR regulated environment.
  • Quality certification and lead auditor certification are advantageous.
  • In-depth knowledge of quality engineering principles, methodologies, and tools.
  • Results-driven with excellent interpersonal skills and communication abilities.

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