Description
Medical Device Quality Engineer - £35,,000 plus benefits - ChesterThis role offers you the opportunity to work for an innovative worldwide company with a massive product range and fantastic facilities. My client have been growing continuously at 7% yoy and they are looking to bolster their QA division.
The Job:
You will be taking responsibility for quality engineering deliverables required within the product development and design change processes. You will support new product development teams in ensuring technical rigor and compliance to applicable procedures during design, development, and transfer to manufacturing. Act as steward for customer requirements/expectations, product safety, quality, and regulatory compliance.
Skills/Experience Required:
- Demonstrated knowledge of Regulatory requirements such as QSR Part 820, MDD 93/42, GMP Parts 210 and 211, ISO 9001 / ISO 13485. Good knowledge of Design Controls.
- Demonstrated knowledge and experience of Risk Management and the application and use of Risk Management Tools such as FMEA, Process Mapping, Hazard Analysis. ISO 14971
- Experience with Quality tools such as Quality Control Plans, Test Method validation and transfer, Statistics, Experimental Designs, Root Cause Analysis, Process validation, Process Optimization.
- Proactive and flexible in adapting to changing environment and able to manage and prioritize work and competing objectives.
- Statistical knowledge, experience is desirable
- Six Sigma knowledge, experience and certification is desirable
- Experience of plastics, extrusion, injection moulding, assembly, bonding.
- Must be proficient with PC programs, i.e. Excel, Word, and PowerPoint. Statistical tools (e.g. Minitab) and MS Project and SAP knowledge desirable.
This role is looking to pay up to £40,000 and is an excellent position for someone looking to embrace an exciting new opportunity. If you are interested in this position, please contact Jonny Montgomery on for further details.