A fantastic opportunity for a Senior 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 great background in Quality Management Systems, training QMS, and mentoring others.
- 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 a pivotal part in maintaining and improving QMS across the site.
- Motivate and monitor performance of sub team to ensure departmental objectives are achieved in compliance with established quality procedures.
- Participate in the interpretation of EU and US regulatory Requirements to produce effective working policies and procedures.
- 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
- Manage and conduct internal and inter-company Quality System Audits with responsibility for the audit process lifecycle.
- Ensure the timely progression of improvement activities resulting from audit findings.
- Support second and third party audits
- 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.
- Supervisory/deputising duties for other team members, as required.
- Support and perform training throughout the company to maintain awareness of the Quality System requirements.
- Work in accordance with Company Quality Standards, procedures and processes and comply with the requirements of GDP and GMP.
- Diploma level Science/Engineering/Quality orientated qualification
- Lead Auditor qualification (ISO 9000 series based quality system essential, ISO13485 preferred)
- Minimum of 3 years experience working in a QA/QS environment within the medical device or pharmaceutical industry.
- Knowledge of ISO13485, Medical Device Directive MDD 93/42/EEC, Regulation (EU) 2017/745 and FDA QSR Part 820
- Good analytical skills and experience of statistical techniques
- Computer literate to include MS Word and Excel and MRP
- Supervisory experience.
- 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.