We’re partnering with an innovative medical device company to hire a Senior Quality Engineer to support manufacturing and production activities within a highly regulated environment.
This is a hands-on role with strong exposure to QMS, manufacturing support, cross-functional collaboration, and continuous improvement. You’ll play a key role in ensuring quality systems are implemented, maintained, and enhanced as the business continues to grow.
Responsibilities:- Support manufacturing activities including equipment qualification, process validation, change control, and continuous improvement
- Partner with Supply Chain on supplier quality and process development
- Develop and review test, part, and design specifications with cross-functional teams
- Drive the day-to-day implementation and improvement of the QMS
- Lead and support internal audits, NC/CAPA, MRB, complaints, and quality review boards
- Provide QA and Design Assurance expertise across projects
- Support regulatory submissions and clinical investigations
- Ensure compliance with FDA, ISO 13485, MDD, and other applicable regulations
Requirements:
- Degree in Engineering, Science, or related discipline
- 5+ years’ experience in a medical device Quality / Design Assurance role
- Recent experience supporting manufacturing in a regulated environment
- Strong working knowledge of FDA & ISO 13485
- Excellent communication and influencing skills
- Strong attention to detail with an analytical, problem-solving mindset
- Ability to work autonomously in a fast-paced environment
What’s On Offer:
- 25 days annual leave
- Competitive health insurance
- 8% employer pension contribution
- Discretionary bonus
- Employee share ownership programme
- Gym membership discounts
- TaxSaver & Bike to Work schemes
- EAP and active Sports & Social committee
If you’re a Senior Quality Engineer looking for a role with real ownership, visibility, and impact in a regulated medical device environment, get in touch for a confidential discussion.
