- Experience Level
- Experienced (non-manager)
Hobson Prior are looking for a Quality Engineer to join one of the worlds leading specialised medical diagnostic organisations. Our client focuses on improving patients lives all over the world by offering specialist diagnostic products to clinicians and laboratory professionals.
- Ensure that the quality management system in manufacturing meets all requirements of all relevant regulatory standards and Regulations: (ISO9001/13485, FDA CFR 820 part 21 , QSR's)
- Work within the QA team located in manufacturing to ensure the company maintains compliance to external and internal quality system requirements.
- To work alongside manufacturing teams and advise on quality related issues/ day to day issues.
- Responsible for assuring that manufacturing processes are in compliance with ISO/cGMP Quality Management System to produce consistent quality product.
- Accountable for identifying opportunities and supporting improvement and reduced variation in the manufacturing processes resulting in improved metrics such as Overall Equipment Effectiveness (OEE), scrap reduction and ability to leverage increased quality for delivery performance improvements, etc.
- Problem solver.
- Work attitude that exhibits drive, creativity, collaboration, assertiveness, good judgment, decision making and ambition.
- Leadership Skills with the ability to influence others and lead significant change.
- Able to work with minimum supervision and as part of a team.
- Strong communication skills and interpersonal skills.
- A level or equivalent is essential.
- Working knowledge of FDA part 820, ISO 13485
- Prior experience of working within QA Engineering or manufacturing QA position in a manufacturing environment within the IVD or Medical Device Industry/ or regulatory industry.
- Good understanding for Quality principles / Quality systems.
- Experience of non-conforming product and corrective action processes.
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.