Remediation Program Quality Specialist

2 weeks ago

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

Job Title: Quality Assurance Specialist

The position of Quality Assurance Specialist offers an exceptional opportunity to contribute to the success of a remediation program. The successful candidate will be responsible for collaborating closely with manufacturing and quality teams to drive compliance improvements and process validation initiatives.

Key Responsibilities:

  • Partner with manufacturing process owners to identify and remediate compliance gaps.
  • Support manufacturing process validation activities, including IQ/OQ/PQ.
  • Update quality system documentation and technical files to ensure audit readiness.
  • Drive closure of CAPAs and NCRs with effective corrective actions.
  • Provide clear and concise technical writing for quality and manufacturing procedures.
  • Collaborate cross-functionally with Quality, Manufacturing, and Regulatory teams to implement compliant solutions.

Requirements:

  • Bachelor's degree in Engineering or Quality-related discipline.
  • 25 years of experience in medical device manufacturing, quality, or remediation projects.
  • Strong knowledge of process validation (IQ/OQ/PQ) and CAPA/NCR management.
  • Proven technical writing and documentation skills.
  • Familiarity with 21 CFR Part 820 and ISO 13485 quality standards.
  • Excellent problem-solving skills with the ability to take a problem statement through to a compliant solution.

Benefits:

This role offers a fantastic opportunity to work directly onsite, collaborate closely with teams, and make a meaningful contribution to compliance improvements and process validation initiatives.

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