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
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