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About the Role
The Quality Manager position is within the Quality and Regulatory Department of JointMedica. You will be taking responsibility for the support and development of the company QMS and will be working for the QA/RA Director. Our needs 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
Requirements
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
About the Company
JointMedica was formed in 2000. We are a small autonomous business, working in friendly co-operation with respected orthopaedic surgeons, experienced engineers, and a variety of cutting-edge manufacturing facilities. We specialise in the creation of products that are highly innovative while at the same time meeting the heightened expectations of patients, along with the stringent quality and safety standards that apply to modern orthopaedic implants.