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We're seeking an experienced Quality Engineer to join a groundbreaking medical device company in the Berkshire area. Our client is in an exciting growth phase, having successfully developed multiple products and secured significant investment. Their technology is improving how various health conditions are detected and monitored, particularly in making screening more accessible in diverse healthcare settings.
Key Responsibilities:
- Lead and support design and development activities in compliance with ISO13485 and EU MDR requirements
- Execute verification and validation processes for medical device products
- Manage technical file submissions and documentation
- Develop and maintain comprehensive risk management documentation
- Conduct and participate in internal and external quality audits
- Work collaboratively with R&D and other cross-functional teams
Key Skills & Experience:
- Minimum 3+ years of quality engineering experience in the medical device sector
- Proven experience with technical file preparation and submission
- Strong working knowledge of ISO13485 and EU MDR requirements
- Experience in risk management and quality system documentation
- Excellent attention to detail and analytical skills
- Strong communication and collaborative abilities
What They Offer:
- Competitive salary range
- Hybrid working arrangement (3 days in office)
- Comprehensive training and development opportunities
- Support from an experienced quality team
- Modern office location and cutting-edge technology
