Our Client is an intimate sized, innovative, medical devices business based in Buckinghamshire who are at the forefront of their technology and have products in over 70 countries worldwide.
Site-based/Remote working split
25 days holiday (plus bank holidays)
This is a fantastic opportunity for someone to take ownership of the Quality Management System, lead and mentor QA Specialist in support, and the ideal candidate will be someone who enjoys being very hands on and constantly striving to improve Quality whilst the business also continues to grow and develop new products.
Manage compliance with requirements of ISO 13485, ISO 9001, CFR 21 part 820, MDR, MDSAP
Design and improve quality management system procedures and specifications as required
- Prepare and communicate Quality Management performance reports
- Maintain a programme of internal and external quality audits
- Maintain the Approved Suppliers List
- Maintain control of the measuring and monitoring devices used in the manufacture and service of products
- Provide ongoing comprehensive QMS training to all employees and ensure all staff are competent in their quality processes and SOP's
- Measure, analyse and report on QMS and production processes
- Manage effective communication and coordination with internal and external customers and suppliers on matters relating to Quality Assurance
- Review customer requirements and ensure they are met - Manage vigilance, CAPAs, risk and design change processes
Nurture a culture of quality throughout the business
Support new product development and continuing engineering projects, assuring project deliverables are compliant with relevant regulations and standards.
Contribute to the team spirit and continual improvement within the company
A minimum of five years electronic medical device quality assurance experience
In depth working knowledge of ISO 13485 and CFR 21 part 820
Internal and external auditing experience
An aptitude to analyse data and create and review processes
Good numerical skills and an understanding of statistics
Excellent MS Office skills (especially spreadsheets using Excel and Google docs)
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.