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Senior Quality Assurance Manager

2 months ago

Neath, Neath Port Talbot, United Kingdom IntaPeople: STEM Recruitment Full time
Quality Systems Team Lead

We are seeking an experienced Quality Systems Team Lead to join our team in Cardiff. As a key member of our Quality Systems team, you will play a crucial role in managing and improving our quality systems.

Key Responsibilities:

  • Ensure compliance with regulatory standards, including CAPA, complaints, post-market surveillance, NCR, document control, inspections, and product release.
  • Assist in interpreting EU and US regulatory requirements and advise design and manufacturing teams to meet these standards during product development and manufacturing.
  • Conduct and manage internal and external Quality System audits, and assist with second and third-party audits of ATL-UK.
  • Analyse data to provide system performance reports to management, review documentation to maintain regulatory compliance, and identify opportunities to enhance system efficiency.
  • Provide supervisory support when needed and conduct training to maintain company-wide awareness of Quality System requirements.

Requirements:

  • Qualification in Science, Engineering, Quality, or Lead Auditor (ISO 9000 series).
  • Extensive experience in QA/QS within the medical device or pharmaceutical industry.
  • Proficiency in MS Word, Excel, and MRP systems.

Please note that this role requires 3 days a week visits to site in Neath - working from home twice a week.