Medasil Surgical Limited is seeking a Quality Control / Assurance Engineer to support manufacturing operations through inspection, compliance, and quality activities. The role is hands‑on and primarily focused on production. The successful candidate shall contribute to maintaining and improving various aspects of the QMS system. The role reports to the QA/RA Director.
Company Description
Medasil Surgical Limited, established in 1974, is a renowned manufacturer of silicone tubing and surgical devices utilized in operating theatres. Based in Leeds, the company supplies high‑quality products to the NHS, private hospitals, and specialist clinics across the UK, as well as exporting globally.
Duties and Responsibilities
- Goods‑in material inspection and product release
- In‑process and final quality control inspections
- Review and sign off batch documentation
- Equipment inspection, maintenance logs and calibration activities
- Environmental and bioburden monitoring
- Cross‑functional departmental training for compliance
- Record and report rejects and rework
- Support Change control, on‑conformance, Supplier approvals and Customer requests
- Assist in maintaining accurate QMS records and documents
- Ensure compliance with ISO 13485, EU‑MDR and UK‑MDR regulations and cGMP
- Support continuous improvement initiatives
- Support validation and FMEA activities
- Maintain safe and clean working area
- Occasional heavy lifting
- Requires walking between various areas, standing, sitting, bending and reaching
Requirements
- Experience in medical device industry or similar regulated environment
- Knowledge of ISO 13485, EU‑MDR and UK‑MDR regulations and cGMP
- Experience working with Quality Management Systems or similar
- Proficient in Microsoft Office applications
- Strong attention to detail
- Excellent written and verbal communication skills
- Minimum of 4 years previous experience in Quality control / Assurance or similar role
- Experience in metrology and understanding technical drawings
- Degree in Engineering, Quality Management, or a related field is preferred
- Knowledge of ISO13485, EU‑MDR 2017/745 and MDD 93/42 / EEC
- LEAN manufacturing understanding
Skills
- Strong organisational and time management skills
- Self‑motivated and adaptable
- Team player with good interpersonal skills
- Ability to work under tight deadlines and change in priorities
If you’re interested in contributing to high‑quality medical device manufacturing in a regulated environment, apply today.
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