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- Tasks: Join us as a Quality Engineer/Specialist, ensuring top-notch quality in medical devices.
- Company: We're innovators in advanced wound care solutions, improving patient care globally.
- Benefits: Enjoy competitive pay, hybrid work, 33 days holiday, and a contributory pension scheme.
- Why this job: Make a real impact in healthcare while working with a dynamic team on global projects.
- Qualifications: A degree in regulatory, science, or engineering; knowledge of medical device regulations is essential.
- Other info: Be part of a culture that values compliance and excellence in a fast-paced environment.
The predicted salary is between 28800 - 48000 £ per year.
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 are 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 the 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 are 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!
Quality Engineer/Specialist in Coventry employer: SFM
Contact Detail:
SFM Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Engineer/Specialist in Coventry
✨Tip Number 1
Familiarise yourself with the specific regulations mentioned in the job description, such as EU MDR 2017/745 and ISO 13485. Understanding these standards will not only help you during interviews but also demonstrate your commitment to quality in the medical devices field.
✨Tip Number 2
Network with professionals in the medical device industry, especially those who have experience in quality management systems. Engaging with them on platforms like LinkedIn can provide insights into the role and may even lead to referrals.
✨Tip Number 3
Prepare to discuss your experience with supplier management and audit programmes. Be ready to share specific examples of how you've contributed to quality assurance initiatives in previous roles, as this will highlight your practical knowledge.
✨Tip Number 4
Showcase your communication skills by preparing thoughtful questions about the company's quality culture and how they implement compliance strategies. This will reflect your proactive approach and genuine interest in contributing to their mission.
We think you need these skills to ace Quality Engineer/Specialist in Coventry
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience and skills that align with the Quality Engineer/Specialist role. Emphasise your knowledge of ISO 13485 and any experience in the medical devices or pharmaceutical industries.
Craft a Compelling Cover Letter: In your cover letter, explain why you are the perfect fit for this position. Mention specific experiences that demonstrate your ability to manage quality systems and compliance within the medical device sector.
Highlight Key Skills: Clearly outline your key skills in regulatory compliance, supplier management, and quality assurance. Use examples from your past roles to illustrate how you've successfully applied these skills.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any spelling or grammatical errors. A polished application reflects your attention to detail, which is crucial for a Quality Engineer/Specialist.
How to prepare for a job interview at SFM
✨Understand the Regulatory Landscape
Familiarise yourself with the Medical Device Regulations, particularly EU 2017/745/EEC and USA 21 CFR 820. Being able to discuss these regulations confidently will demonstrate your knowledge and suitability for the role.
✨Showcase Your Quality Management Experience
Prepare examples from your past work where you successfully managed quality systems or led supplier audits. Highlighting specific achievements will help illustrate your capabilities and how they align with the company's needs.
✨Emphasise Team Collaboration Skills
As this role involves working closely with cross-functional teams, be ready to discuss how you've effectively collaborated in previous positions. Share instances where your communication skills made a positive impact on team outcomes.
✨Prepare Questions About the Company
Research the company’s products and recent developments in wound care solutions. Asking insightful questions about their innovations or future projects shows your genuine interest and enthusiasm for the role.
