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Quality Engineer/Specialist
Location: Coventry, CV3 2RQ
Salary: Competitive (DOE)
Contract: Full-Time, Permanent
Why Join Us
Innovate in Healthcare - Be part of a forward-thinking medical devices company developing cutting-edge wound care solutions.
Make an Impact - Play a key role in ensuring regulatory compliance for life-changing medical products.
Global Reach - Work on regulatory strategies that impact markets across the UK, EU, USA, and beyond.
Perks & Benefits
• Competitive salary
• Contributory pension scheme
• Hybrid/Flexible working
• 33 days holiday (including bank holidays)
• Life cover & incapacity benefits
• Cash Back Medical Scheme
About Us
We're not just a medical devices manufacturer - we're innovators in advanced wound care solutions. Our high-quality, cost-effective products improve patient care and wellbeing worldwide.
Your Mission
As a Quality Engineer/Specialist, you will be responsible for supporting the management and continued effectiveness of Quality Management System within the business.
The Quality Engineer/Specialist will work closely with the Quality Manager to develop and deliver a range of proactive and responsive QMS and Supplier Quality Assurance (SQA) initiatives.
Key tasks and responsibilities:
• Lead supplier management including qualifications, performance evaluations, complaints, and corrective actions (SCARs),
• Lead the management of the business product and process change control programme,
• Lead the maintenance and management of the SFM training programme, ensuring training matrices and records are maintained,
• Lead the asset calibration programme,
• Support the management and co-ordination document control within the business via the use of the electronic document control systems, contributing to the drafting of documentation, managing the review, approval and distribution of documents including procedures, SOPs, WIs, and forms within the SFM QMS,
• Support the management and maintenance of the business integrated quality management system,
• Support the delivery and management of the business nonconformity programme,
• Support the delivery of the business' audit programme including internal, customer, external, and leading the supplier audit programme,
• Deputise for the Quality Manager as required,
• Contribute to create and maintain a proactive leadership style and compliance culture throughout the company to achieve high standards of excellence, sharing best practice,
• Deliver any other duties as required by the line manager.
Compliance responsibilities:
• Adhere to and deliver the compliance scheme with the SFM regulatory, compliance and quality structure
Key Skills/ Abilities
• Regulatory, science or engineering degree or equivalent
• Knowledge of the Medical Device, Regulation EU 2017/745/EEC, USA 21 CFR 820, UKCA
• A demonstrable working knowledge and experience of applying ISO 13485, USA 21 CFR 820, EU MDR 2017/745, and Canada SOR 98.282 requirements within the Medical Devices or Pharmaceutical industries
• Dynamic and pragmatic team member and flexibility to work within the dynamics of a cross-functional team
• Strong communication skills
Desirable Additional Experience:
• ISO 13485 auditor qualification desirable
• Advanced wound care manufacturing an advantage
• Cleanroom experience an advantage
Ready to Make an Impact
APPLY NOW! Send us your CV and cover letter explaining why you're the perfect fit.
Note: Due to high application volumes, only shortlisted candidates will be contacted. We reserve the right to close applications early. No agencies, please!
