An opportunity has arisen within the Quality team for a Design Quality Engineer at Winsford. The role will work closely with site Manufacturing, R&D and Regulatory Affairs as well as other functions to standardise design control and risk management process across group, and in supporting processes to deliver high quality and innovative medical device launches on time. The role will report to the Group Quality Manager.
- Set-up standardised design control and risk management process across groups
- Develop, generate and maintain document template to support an effective and compliant Quality Management System, including:
- Medical Device Risk Management Files
- Quality Control Plans and Sampling Plans
- Product and material specifications
- Support R&D in creation of Design History Files
- Support Regulatory Affairs in creation of Regulatory Files.
- Utilise standard Quality Engineering toolkit to drive continuous improvement to products, processes and systems.
- Provide quality input to new product developments and extensions to existing product lines, identifying product and process CTQs.
- Participate in external audits of AMS from Customers and Regulatory Agencies.
- Work effectively with colleagues to participate and contribute to the successful completion of personal, team and business goals and objectives.
- Maintain an understanding of current Medical Device standards, directives and regulations in design control and risk management.
- Represent AMS Ltd professionally to external customers, suppliers and regulatory bodies.
- Represent the Quality Department at on site and off site meetings as required.
- Travel to other AMS group and supplier facilities as required.
- Coach and/or mentor staff as required.
The ideal candidate will have:
- A degree or equivalent qualification in an STEM subject or equivalent industry experience.
- Previous experience in new product design or quality engineering (medical device experience required).
- Working knowledge of and experience in developing products in a regulated environment and to the requirements of cGMP, CFR 21 Part 820, MDD 93/42/EEC, ISO 13485.
- Fundamental understanding of quality management system and its development, documentation and implementation.
- Working knowledge of risk management, risk assessment tools and techniques and reporting in accordance with ISO 14971.
- Ability to manage own time effectively, prioritise tasks and deliver to critical deadlines.
- Excellent commutation skills; written, verbal and presenting.