An innovative leader at the forefront of enhancing patient care worldwide are growing their Quality Systems team in Cardiff. As a Quality Engineer (we’re hiring for both Senior and Mid-level) you'll play a key role in managing and improving quality systems.
Key Responsibilities:
You will ensure compliance with regulatory standards, including CAPA, complaints, post-market surveillance, NCR, document control, inspections, and product release.
You will assist in interpreting EU and US regulatory requirements, and advise design and manufacturing teams to meet these standards during product development and manufacturing.
You will conduct and manage internal and external Quality System audits, and assist with second and third-party audits.
Additionally, you will analyse data to provide system performance reports to management, review documentation to maintain regulatory compliance, and identify opportunities to enhance system efficiency. You will also provide supervisory support when needed and conduct training to maintain company-wide awareness of Quality System requirements
Knowledge/experience we’re most interested in:
- 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 this role requires 3 days a week visits to site in Cardiff - working from home twice a week. Please apply now to be considered, or email Rachael on r.maule@intapeople.com for a confidential discussion.