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.
Job Type: Full-time
Pay: £28,000.00-£30,000.00 per year
Benefits:
* On-site parking
Application question(s):
* Do you have experience working in the Medical Device Industry or similar highly regulated environment?
* Are you knowledgeable in ISO 13485, EU-MDR and UK-MDR regulations and cGMP?
Education:
* Bachelor's (preferred)
Experience:
* Quality assurance: 4 years (required)
Work authorisation:
* United Kingdom (required)
Work Location: In person