A fantastic opportunity for a Quality Engineer to join our medical device client who design, develop and manufacture medical devices under one roof. This will suit someone who has a background in Quality Management Systems in highly regulated industry (ideally medical devices but could be Aero/Auto)
- Hybrid working
- Pension scheme
- Life assurance
- Private Medical
- 25 days annual leave, plus bank holidays
Working within the Quality Systems Team that covers CAPA, Complaints, Non-Conformance Reports, Document Control, Inspections and Internal Audits, Product Release, and post market surveillance, you will play your part in maintaining and improving QMS across the site.
- Implement and monitor established policies and procedures to ensure compliance with necessary regulatory bodies in the areas of: Corrective and Preventive Action (CAPA), Complaint, Post Market Surveillance and Non-conformance Report (NCR).
- Provision of advice according to established procedures relating to CAPA, Complaint, Post Market Surveillance and NCR and against the external requirements of the relevant regulatory authority (ISO13485:2003, Medical Device Directive MDD 93/42/EEC and 21 CFR Part 820) and local quality standards.
- Provide effective solutions/advice to design and manufacturing teams on established procedures to ensure products are designed and developed and manufactured according to the requirements of the relevant regulations
- Provide reports to management to enable them to monitor system performance.
- Review and authorise documentation and processes in the Quality Management System to ensure compliance with established quality procedures and applicable regulations and alignment with other related documentation.
- Identify and collaborate in the implementation of changes to the Quality System to increase efficiency and/or effectivity whilst ensuring compliance with applicable regulations.
- Support and perform training throughout the company to maintain awareness of the Quality System requirements.
- Support and conduct internal and inter-company Quality System Audits in line with local and group objectives.
- Minimum A level or equivalent in a Science/Engineering/Quality orientated qualification
- Minimum of 3 years' experience working in a QA/QS environment within the medical device or pharmaceutical industry or similar highly regulated industry
- Ideally knowledge of ISO13485:2003 and Medical Device Directive MDD 93/42/EEC
- Ideally knowledge of FDA QSR Part 820
- Computer literate to include MS Word and Excel and MRP
- Knowledge of GMP and audits
- Ability to work with minimal supervision and use initiative.
- Good inter-personal skills and the ability to communicate well in English both written and orally.
- Good record/documentation skills.
- Works with integrity, customer focus, accountability and teamwork.
For immediate consideration please forward your most up to date CV
Austin Fraser is acting as an Employment Agency in relation to this vacancy.
Austin Fraser is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status.
Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants.