Quality Assurance Manager

CK Group; North East; On-site; GBP 40,000 - 60,000; Full time

Job summary

A leading manufacturer of medical and technical products is seeking a Quality Assurance Manager based in County Durham. The role involves managing the Quality Management System, ensuring compliance with relevant quality standards, and driving quality improvements across the organization. Applicants should have a degree and QA experience in an ISO 13485 regulated environment. This is a permanent, site-based position.

Qualifications

• Educated to degree level or above in a relevant field.
• QA experience in an ISO 13485 regulated environment.
• Ability to manage the Quality System and deal with non-conformance appropriately.

Responsibilities

• Take ownership of the Plant Quality Management System.
• Design and maintain quality management systems, policies, and procedures.
• Ensure compliance with ISO 9001, ISO 13485 and ISO 22716.

Skills

QA experience in an ISO 13485 regulated environment

Ability to manage the Quality System

Diligent and accurate

Skilled in Microsoft Office

Education

Degree level education in a relevant field

Job description

Overview

CK Group are recruiting for a Quality Assurance Manager to join a leading manufacturer of Medical and Technical products who are based in County Durham on a permanent basis.

Location

The role is based in County Durham and is site based.

Responsibilities

• Take responsibility for overall ownership of the Plant Quality Management System and for monitoring and assuring the quality of all incoming materials, outgoing materials, work in progress materials and also the quality of all physical and transactional processes.
• Design, implement, and maintain quality management systems, policies, and procedures.
• Ensure that the Quality Management system in place conforms with all relevant Quality standards which include ISO 9001, ISO 13485 and ISO 22716
• Manage and update the site Quality Manual and conduct Training
• Ensure the legal compliance of New Products
• Establish standards and processes to ensure that defects are prevented from occurring in the first place
• Contribute to the long-range strategy for quality within the organisation
• Complete Internal Audits to a high standard and follow up by closing actions
• Promote quality awareness and ensure compliance with quality standards, both internal and external
• Supplier audits
• Drive improvements in quality performance across the organisation

Your Background

• Educated to degree level or above in a relevant field.
• QA experience in an ISO 13485 regulated environment.
• The ability to manage the Quality System and deal with non-conformance appropriately.
• Must be diligent and accurate.
• Skilled in the use of Microsoft Office.

Apply

For more information, or to apply for this Quality Assurance Manager position please contact Mary Bolt on 01246 457733 or email [e-mail]. Please quote job reference 153 010 in all correspondence.

It is essential that applicants hold entitlement to work in the UK