Quality Assurance Manager

Job content

Quality Manager, to £55k

We’re looking for an experienced Quality Manager or Regulatory Manager to join an incredible Oxford-based medical technology company.

What will I be doing?

Working closely with the heads of departments, and reporting directly to the CEO, you will have day-to-day responsibility for the Quality Management System, designing, implementing and maintaining ISO 13485-ready processes and documentation, as well as ensuring that all staff are trained in and adhering too, the QMS.

You will also be responsible for the preparation of documentation to support clinical trials, and will lead on the evaluation, selection and implementation of an eQMS.

About the company

Spun-out of an existing, successful scientific R&D firm over 5 years ago, you will be joining a talented and dedicated team as they continue to develop proof of principle technology into a fully functioning MHRA-approved product prototype. Using ultrasound technology, the company has developed a novel, minimally-invasive surgical procedure that has the potential to transform spinal surgery.

The ideal candidate will have…

• Experience in compiling technical documentation for class II and/or class III medical devices
• Experience of maintaining an ISO 13485 Quality Management System
• Experienced in interpreting the regulatory requirements for medical devices in the EU and/or USA
• Experience in providing regulatory support for new product development and/or early stage medical device companies would be highly-advantageous
• Experience of eQMS solutions such as Codebeamer X, Dot Compliance, Greenlight Guru, etc., would be useful
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Next Steps

This is an excellent opportunity you to make the next step on your career and to embrace a new challenge.

If you’re interested in the role then please apply now for immediate consideration.