quality manager Worcester, England
Job description
Job Advert
Our client JointMedica are looking for an experienced Quality Manager to join their Quality and Regulatory Department. You will be taking responsibility for the support and development of the company QMS and will be working for the QA/RA Director. The role will cover a wide range of disciplines including product design, testing, manufacture, procurement and sales. Ideally you will have experience in an engineering environment and a good understanding of the standards expected in the medical device arena. Familiarity with materials and methods used in the production of orthopaedic devices will also be an advantage.
Essential Functions
Management of a team of Quality Engineer and part-time QA Assistant- Development and maintenance of the ISO 13485 Quality Management System to applicable regulatory requirements
- Completion and maintenance of Quality System records
- Development and maintenance of up-to-date legislative and regulatory knowledge to ensure product and QMS compliance
- Delivery of internal QMS training
- Internal and Supplier Audits
- Management of third body audits
- Communicating with and engaging outside agencies/regulatory bodies
- Complaint management
- Change Management (document and product change)
- Management of Corrective and Preventive actions
- Support of validation of internal and external processes
- Support regulatory documentation and submissions as required
The successful candidate will have:
Have experience in quality engineering or similar QA role- Have good understanding of the quality tools required
- Possess strong problem-solving skills
- Have good attention to detail
- Take a risk managed approach to improvement
- Be able to work with staff at differing levels of the organisation
- Have the desire to improve the effectiveness of procedures and systems
- Possess strong communication skills
- Be a team player
- Be versatile and a self-starter able to work without supervision
- Have good PC skills; experience of eQMS systems would be an advantage
Salary
£45,000 to £50,000 p.a. depending on experience.- Nest Pension.
- 20 + days annual leave, plus Bank Holidays.
- Death In Service Benefit.
- Free on-site parking.
- Full on-site training given.
If you are interested in the role and have the right experience please apply with your CV and Clover HR will be in touch!
