Senior Quality Systems Lead

Senior Quality Systems Lead

£50,000 - £55,000 + company pension, healthcare, life assurance & excellent additional benefits

Blackwood

Do you want to work for a world leader in serving science that can boast the largest investment in research and development in the industry? Are you looking for a varied role with a global company where you will be able to make a positive impact and mould a department around your way of working?

If so, please read on.

We are recruiting for a Senior Quality Systems Lead for a genuine industry leader and employer of choice in Blackwood. This is a fantastic opportunity to be a senior figure in a forward thinking, innovative quality environment.

As Senior Quality Systems Lead you will:

- Display up-to-date knowledge, and demonstrated experience in driving and sustaining improvement to the Quality Management System to ensure compliance to ISO 9001, ISO 13485, and ISO 14971 standards, and In-Vitro Diagnostics Regulation (IVDR).

- Maintain and update the QMS system to ensure compliance with current regulations and standards and approval according to ISO 9001 and ISO 13485.

- Manage customer facing quality processes to provide timely and professional reply to customer complaints, requests for information, host of audits, quality agreements etc.

- Act as the local point for ISO, Regulatory and Customer Audits of the Quality Management System.

- Manage the internal audit program and identify areas of non conformance

- Oversees the corrective actions and preventive actions (CAPA) process and monitor its performance.

- Monitor all reports of non-compliance resulting from customer, registrar and regulatory audits to ensure corrective action plans are in place

- Ensure that site procedures are in alignment with divisional and corporate quality guidance documents.

Qualifications required

- Minimum 3 years' experience in Quality Systems Management.

- Working experience with ISO 13485 and compliance with Medical Devices (MDD 93/42/EEC, FDA 21 CFR Part 820).

- ISO 13485:2016 Lead Auditor Certification preferred.

This senior role comes with a very competitive salary and great benefits. The company in question employs over 70,000 people worldwide and you will have the chance to play a very important part in the manufacturing process across the board. This role comes at a time when the company is growing considerably.

For immediate consideration, please forward your CV to Alex at Vibe Recruit today.

Vibe Recruit is acting as an Employment Agency in relation to this vacancy.