Quality Systems Manager

Job title : Quality Systems Manager
Location : Cambridge
Job type : Permanent
Salary : Competitive
Contact name : Gabriella Boxall
Contact number : +44 (0) 207 255 6655
Contact email : gabriella.boxall@seclifesciences.com
My client is an ambitious point of care diagnostic organisation. Their focus lies within in-vitro diagnostics (IVD); by using unique approaches and continuous monitoring, they are able to provide faster, cheaper and safer diagnostics. They are primarily addressing the COVID-19 pandemic, and will begin shifting their focus on other diseases, such as para-influenza and Strep A. Although my client is a start-up company, they are rapidly growing due to recent funding from a global partnership. Due to this, they are searching to expand their team and welcome a Quality Systems Manager.

The quality systems manager is responsible for all aspects of the quality system, ensuring regulatory compliance is met. Working with critical functions within the organisation, they will report to the Chief Operating Officer.

Your Responsibilities:
* Maintain and manage the eQMS, as well as acting as the Quality Systems Management Representative.
* Managing the organisations audit programme, including but not limited to: internal, certification, Notified Bodies and supplier.
* Act as Subject Matter Expert (SME) to applicable standard and regulatory requirements - including awareness of and compliance to regulatory (ISO 13485, 21 CFR Part 820/ QSR, IVDR)
* Have ownership of quality training programme, undertaking quality and compliance training when needed to ensure a united approach to quality.

Your Requirements:
* Experience of Quality Management, Quality Systems and/or Quality Assurance, with demonstrable knowledge
* Life science Master's degree (or an equivalent qualification)
* Proven experience in maintaining positive interactions with auditing organisations and notified bodies
* Prior development and maintenance of a QMS, including a thorough understanding of medical device standards (e.g. ISO 13485 and 14971)
* Experience with electronic quality system software, such as System Administrator

Your Benefits:
* Competitive salary, with a profit related bonus
* Generous employer pension, with a 12% contribution of pensionable salary
* Private medical insurance and life insurance
* 25 days annual leave holiday, plus bank holidays
* Comprehensive relocation package available
* Wide range of discounts/memberships to sports facilities and theatre

You can be apart of this ambitious organisation, apply now! Contact gabriella.boxall@seclifesciences.com for similar jobs, or call +443300528483