I am currently working with a Medical Device/Pharmaceutical company based in Cambridge who are looking for a Senior QA Engineer to join the team.
As Senior QA Engineer, you will provide superior Quality Support to Supply Chain and Device Industrialisation, to ensure products are manufactured in accordance to applicable industry standards, regulatory requirements, and customer requirements.
- Support the analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary.
- Implement protocols and methods (including SOP's) to ensure that incoming material and manufactured products are compliant with internal requirements as well as to standards/regulations.
- Drive Key Process Indicators to determine process effectiveness, identify areas for improvement, best practices, scrap reduction and Supplier Quality improvement and drive continuous quality improvement projects with cross-functional teams.
- Drive and manage corrective and preventive actions for issues related to quality.
- Work closely with production line and ensure all necessary controls are enforced to be compliant with ISO 13485 and FDA QSR requirements.
- Perform audits (Product-Specific and Quality System) and follow up on closure of any non-conformances; support supplier approval process and maintenance of the Approved Suppliers List and implement Quality Technical Agreements.
- Maintain existing Quality systems by completing tasks as assigned by Quality Team Leader/Manager.
- Experience of working in a product development environment utilising CMOs for manufacture and supply
- Good knowledge and experience of quality engineering tools such as APQP, SPC and SCAR.
- Hands-on experience of electro-mechanical medical devices including Class I and Class IIa devices and PCB testing
- Experience in evaluation and trending of dimensional data.
- Experience with technical drawings and specifications.
- Proven ability to use the quality, complaints, design control, corrective and preventive action, risk management, and non-conforming product systems and to extract and drive improvement initiatives.
- Demonstrable experience in supplier quality management: quality concepts/tools/methods (e. g. FMEA, IQ/OQ/PQ, MSA, etc.), quality issue resolution and quality monitoring measures.
- Highly experienced in leading internal and external audits
If you'd like to learn more about this opportunity, please reach out as soon as possible!
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales