A highly innovative medical device manufacturer is actively looking for an experienced Senior Quality Systems Engineer to join their team. They are genuinely revolutionising certain applications within their field and the successful candidate will be working on high tech, innovative products which will have a huge impact on people’s lives.
The successful candidate will provide support to the management and improvement of quality systems processes to ensure both EU and US regulatory compliance to relevant company standards and Good Manufacturing Practice (GMP).
Duties & Responsibilities
- Deputise for QS Manager when required, to ensure progression of departmental commitments.
- Supervisory responsibility for QS Engineers.
- Motivate and monitor performance of sub team to ensure departmental objectives are achieved in compliance with established quality procedures.
- 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).
- Review and provide information to National Competent Authorities on behalf of Olympus business centres to ensure their compliance with the Medical Devices Vigilance system.
- Participate in the interpretation of Regulatory Requirements (ISO13485:2003, Medical Device Directive MDD 93/42/EEC and 21 CFR Part 820) to produce effective working policies and procedures.
- 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 and local quality standards.
- Interpretation of RA requirements to provide technical and system advice/guidance as necessary to ensure compliance to 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
- Analyse data, including the use of statistical techniques, to 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.
Skills & Experience
- Diploma level Science/Engineering/Quality orientated qualification
- Minimum of 3 years’ experience working in a QA/QS environment within the medical device or pharmaceutical industry.
- Knowledge of ISO13485:2003, Medical Device Directive MDD 93/42/EEC and FDA QSR Part 820
- Good analytical skills and experience of statistical techniques
- Computer literate to include MS Word and Excel and MRP
- GMP and audit qualifications
- Supervisory experience.
- Works with integrity, customer focus, accountability and teamwork.