Senior Quality Assurance Engineer
3 weeks ago
We are seeking a highly skilled Senior Quality Assurance Engineer to join our team in Cambridge. As a key member of our quality assurance department, you will be responsible for ensuring the delivery of high-quality medical devices and combination products.
Key Responsibilities:
- Lead design control and risk management activities for combination product development programs
- Support effective risk management activities at external design companies and manufacturing facilities
- Ensure combination product development activities are compliant with quality and regulatory standards
- Provide input and support to design validation including human factors engineering assessments
Requirements:
- BSc/MSc/PhD in appropriate science & engineering discipline with 2+ years of experience in pharmaceutical combination product and/or device industries
- History of working in accordance with ISO 13485, ISO 14971, 21 CFR 820, and EU Medical Devices Regulation
- Understanding of Good Manufacturing Practices (GMP)
Salary Estimate: £60,000 - £80,000 per annum depending on experience and qualifications
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