Quality Engineer - Compliance
Quality Engineer - Compliance
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Salary Not Disclosed
1 Vacancy
Job Description
TekWissen is a global workforce management provider throughout the UK Europe and many other countries in the world. The below client is an American multinational pharmaceutical and biotechnology corporation.
Location: Cambridge UK (2-3 days on-site per week)
Duration: 12 Months ( 37hrs per week )
Job Description:
- The Quality Engineer - Compliance will be responsible for providing design control and risk management expertise to medical device and combination product development programs throughout the product lifecycle.
- This includes the generation and review of design history and risk management file components as well as collaboration with cross-functional development teams.
- Lead and manage design control and risk management activities for combination product development programs.
- Ensure deliverables are compliant with clinical trials and commercial licensure requirements.
- Facilitate risk management activities with external design companies and manufacturing facilities.
- Ensure product development activities comply with internal and external quality and regulatory standards.
- Provide input and support for design validation including human factors engineering assessments.
- Support regulatory submission data generation for assigned device projects.
- Assess external design companies and suppliers capabilities related to device development and supply.
- Support device design and manufacturing investigations during clinical trials and commercial manufacture.
- Assist in internal and external audits of the DCoE Quality Management System.
- BSc MSc or PhD in a relevant science or engineering discipline (e.g. chemistry biology biomedical sciences mechanical engineering materials sciences chemical engineering).
- Minimum 5 years of relevant experience in the pharmaceutical combination product and/or device industries.
- Experience in design controls and risk management for combination products.
- Familiarity with ISO 13485 ISOCFR 820 21 CFR 4 and EU Medical Devices Regulation
- Proficient in ISO 9001 ISO 13485 ISOCFR 820 21 CFR 4 and EU Medical Devices Regulation.
- Knowledgeable in EN 62366 EN 60601 and EN 62304 standards.
- Familiar with Human Factors Engineering and device assembly manufacturing processes.
- Strong attention to technical details and accuracy.
- Ability to work independently and prioritize multiple tasks.
- Decisive: Agile learner with the ability to synthesize complex information.
- Focused: Accountable for meeting the needs of customers and stakeholders.
- Connected: Effective in building professional relationships with stakeholders.
- Courageous: Consistent and trustworthy in actions and decisions.
- Resilient: Adaptable to shifting priorities in response to organizational needs.
- Ability to sit for extended periods.
- Willingness and ability to travel.
- Possession of a valid driving license.
Employment Type
Full-time
