Quality Control/Assurance Engineer
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Job Summary
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
Essential:
• 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 year's previous experience in Quality control/Assurance or similar role
• Experience in metrology and understanding Technical drawings.
Desirable:
• Knowledge of ISO13485, EU-MDR 2017/745 and MDD 93/42/EEC
• LEAN manufacturing understanding
• Cleanroom experience
• Degree in Engineering, Quality Management, or a related field is preferred
Skills
• Strong organisational and time management skills
• Self-motivated and adaptable
• Team player with good interpersonal skills
• Good manual dexterity
• Ability to work under tight deadlines and change in priorities
• Internal auditor (preferable)
If you're interested in contributing to high-quality medical device manufacturing in a regulated environment, apply today.