Senior Quality Assurance Specialist
4 weeks ago
Quality Assurance Specialist
IntaPeople is seeking a Quality Assurance Specialist to join their team in Cardiff. As a Quality Assurance Specialist, you will play a key role in managing and improving 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.
- 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.
- Knowledge of ISO 13485, MDD 93/42/EEC, Regulation (EU) 2017/745, and FDA QSR Part 820.
- Proficiency in MS Word, Excel, and MRP systems.
- Supervisory experience with strong analytical and statistical skills.
Please note that this role requires 3 days a week visits to site in Cardiff - working from home twice a week.
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