Quality Systems Manager

Overview

A fantastic opportunity for a Quality Systems Manager to join our medical device client who design, develop and manufacture medical devices. The role will be based in Cambridge but offers a mix of flexible working, and will suit someone who has experience of Medical Devices going from early phase/new concept development to clinical trial ready products and will be the Quality Lead on site.

Benefits

• Hybrid working

• Pension scheme (8% employer contribution, 3% employee)

• 28 Days annual leave (plus bank holidays)

• Medical/Dental/Health Insurance

• Bonus

• Relocation offered

Responsibilities

• Managing/Improving the ISO13485 QMS

• Manage and Conduct Internal and External Audits

• Providing Quality Training and Development to the Team

• Being the Site SME for Quality

• To develop / maintain relevant legislative, compliance, and regulatory knowledge

• Producing/delivering accurate & reliable reports and presentations of regulatory data

Required Skills

• Experience of working within an ISO 13485 quality system for the design and development of medical devices

• Working knowledge and experience of compliance with the Medical Devices Directive and US FDA 21 CFR.

• Experience of facilitating and supporting internal and external quality system audits.

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For immediate consideration please forward your most up to date CV.

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If you would like to find out more about this role or similar med tech jobs, please get in touch with our tech recruiters at Austin Vita.