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Quality Manager - Medical Devices

Employment Type:
Type of Job:
Regulatory Affairs
East Anglia
35,000 to 50,000 per annum
Salary Description:
£35000 - £50000 per annum
UK Pound
Star Medical
Job Ref:

Quality Operations Leader

Star is recruiting for a Quality Operations Leader! Our client provides innovative solutions and support to help healthcare professionals to ensure safety, enhance patient outcomes and improve the total cost of care. They are passionate about improving and saving the lives of patients through high quality, innovative medical devices and services. Their product portfolio revolves around Pain Management, Respiratory and Vascular devices.

The responsibilities of a Quality Operations Leader:

* Checking, editing and confirming the quality system according to national and international regulations, standards and established policies / procedures
* Writing functional procedures (SOPs) and work instructions (DPs) to meet the criteria of the quality system aligning and implementing divisional and corporate documentation
* Maintaining the document control system and providing input to change control
* Coordinating the internal audit program, developing and executing plans and following international audit reports and developing corrective actions
* Timely and accurate provision of QC / Quality Operations responsibilities

The ideal candidate will be/have:

* Experience within the medical devices industry
* Knowledge of and experience with (use of) quality ISO 13485 and ISO 9001 and 21 CFR 820)
* Knowledge of 21 CFR 820, GMP and GDP guidelines
* Experience having worked as an internal or lead auditor is ideal
* Proven ability to formulate Quality Operations facility strategies
* Excellent business acumen and ability to work in fast-paced and high-growth environment
* Demonstrable experience of managing a team

Apply for this opportunity now via the website or contact Jon Woodrow at the Bath Office!

Star is a full service resourcing and outsourcing company which resources at all levels for pharmaceutical, medical devices and technology, clinical research and healthcare communications companies in the UK and Ireland on a headcount and outsourced basis. If you haven't heard from us within 7 working days of submitting your application, please assume that you haven't been successful on this occasion. We wish you the best of luck with your job search.

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