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Product Quality Manager - Medical Devices

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    Will Godfrey

  • Published

    15 days ago


Austin Vita has a fantastic opportunity for a Quality Manager with Medical Devices experience to join our client based in Oxfordshire. You will be accountable for all quality and compliance aspects related to the manufacture and release of medical devices and medicinal products, so that supply levels are maintained, issues are communicated and resolved efficiently.

This will include:

· Responsibility for the quality compliance of all aspects for product quality from site and for driving improvement initiatives

· Responsibility for the release of product from the site that meets specification - both medical devices and medicinal products

· Representing Quality as part of the site management team

· Accountability for all product quality discussions and communication with the site GM

· Being responsible for the Quality Scorecard so that all areas of the business support the measures

· Managing the team of direct reports and dotted line associates for the management of all customers for all day to day quality activities

· Accountability for quality compliance relating to key account customer's product - including exceptions, change control, audits, coordination of other quality activities (e.g. validation, risk management and regulatory affairs) and liaising with batch release.

People Leadership:

· Lead team members on a day to day basis

· Establish training plans for all reports

· Perform annual appraisals

· Schedule and plan activities across team members and monitor progress

· Establish regular meetings (including 1:1s) with team members

Knowledge and Expertise:

· Knowledge of ISO13485, cGMP, CRF820

· Knowledge of medicinal product GMP (preferable)

· Experience of Quality Management Systems - medical devices (essential) and medicinal product (preferable)

· Experience in driving continuous improvement

· Ability to confidently interact with key customers


· Educated to degree level (or similar experience)

· Lead auditor (ISO13485) certificate preferable

· Highly computer literate (Word, Excel and Powerpoint)

You will be rewarded with a great salary and benefits, and the opportunity to develop your career in a fast paced environment with a great breadth of medical devices and medicinal products.

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.