Job Title
Quality Engineer
Contract Duration: 12 months
Location: Cambridge, UK (2-3 days a week on site)
Estimated Salary: £35,000 - £55,000 per annum (PAYE rate max up to £21.62 p/h and Umbrella rate max up to £24.23 p/h)
About the Role
This Quality Engineer position is part of the Biotherapeutics Pharmaceutical Research and Development Devices Centre of Excellence in Cambridge, UK.
The successful candidate will provide design control and risk management expertise to medical device and combination product development programmes throughout the product lifecycle.
* Lead design control and risk management activities for combination product development programs.
* Support and facilitate 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.
* Support the assessment of external design companies and suppliers for capability of quality systems, facilities, and procedures.
* Support device design and manufacturing investigations.
* Support the generation of all regulatory submission data and content for assigned device projects.
* Support internal and external audits of the DCoE Quality Management System.
Requirements
* BSc in an appropriate science or engineering discipline (chemistry, biology, biomedical sciences, mechanical engineering, materials sciences, chemical engineering) with a minimum of 2 years of relevant experience.
* MSc or PhD in an appropriate science or engineering discipline with relevant experience.
* Familiarity with ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and the EU Medical Devices Regulation.
* Experience in design controls and risk management for combination products.
* Familiarity with Human Factors Engineering and device assembling manufacturing processes.
Skills and Competencies
* Working knowledge of ISO 9001, ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and the EU Medical Devices Regulation.
* Familiarity with EN 62366, EN 60601, and EN 62304.
* Excellent communication and interpersonal relationship skills.
* Proficiency in general computer software such as word processing, spreadsheets, presentations.
* Understand Good Manufacturing Practices (GMP).