Quality Assurance Specialist
3 weeks ago
Job Title: Quality Assurance Specialist
Location: Cambridge, UK
Clinical Professionals Limited is seeking a Quality Assurance Specialist to join their team in Cambridge, UK.
The ideal candidate will have a strong background in quality assurance and regulatory compliance, with experience working in the medical device industry.
Salary: £60,000 - £80,000 per annum.
Job DescriptionThe Quality Assurance Specialist will be responsible for ensuring that all medical devices developed by Clinical Professionals Limited comply with relevant regulatory requirements.
This includes developing and implementing quality management systems, conducting audits and inspections, and providing training to staff on quality procedures.
- Lead design control and risk management activities for combination product development programs, ensuring deliverables are appropriately authored, approved, and maintained to support clinical trials and commercial licensures.
- Support and facilitate effective risk management activities at external design companies and manufacturing facilities related to assigned projects.
- Ensure combination product development activities are compliant with quality and regulatory standards, both internal and external.
- Provide input and support to design validation including, but not limited to, human factors engineering assessments.
- Support the assessment of external design companies and suppliers for capability of quality systems, facilities, and procedures to support device development and supply.
- Support device design and manufacturing investigations from devices used in clinical trials and commercial manufacture.
- Support the generation of all regulatory submission data and content for assigned device projects.
To be successful as a Quality Assurance Specialist, you will need:
- BSc in appropriate science & engineering discipline (chemistry, biology, biomedical sciences, mechanical engineering, materials sciences, chemical engineering; or other related discipline) with a minimum of 2 years of relevant experience in the pharmaceutical combination product and/or device industries.
- OR
- MSc in appropriate science & engineering discipline (chemistry, biology, biomedical sciences, mechanical engineering, materials sciences, chemical engineering; or other related discipline) with a minimum of 2 years of relevant experience in the pharmaceutical combination product and/or device industries.
- OR
- PhD in appropriate science & engineering discipline (chemistry, biology, biomedical sciences, mechanical engineering, materials sciences, chemical engineering; or other related discipline).
- History of working in accordance with the requirements of ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and the EU Medical Devices Regulation.
- Understand Good Manufacturing Practices (GMP).
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