Quality Management Systems Manager

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Overview:

I am partnering with an industry leading Medical Device organisation to secure a QMS Manager who will be based on site in North London/Hertfordshire. The QMS Manager will be a global partner and leader of the QMS team with responsibility for delivering the strategic, compliance and business objectives of the function.

The successful QMS Manager will be a great leader with proven experience of creating and managing high performing teams and be able to lead cross-functional teams, ideally across multiple sites. It is also necessary for the QMS Manager to possess great communication and project management skills.

The QMS Manager will report into the QARA Director and have excellent opportunities for training, development and career progression.

Success in this role will require at least 6 years of experience relevant experience in the Medical Device industry and at least a year of experience of growing & leading teams.

Key Responsibilities:

* Document Control, Change Management, CAPA and QMS teams

* Ensure development of talent and a sustained high level of engagement

* Ensure strategic and global alignment of the QMS strategy with the Divisional and Corporate directions. Responsible for development of best in class QS practices

* Responsible for oversight of all activities related to the maintenance of the QMS

* Assessment and approval of change control of quality system (BPO/QA approval)

* Responsibility & oversight of the change control processes and review forums, ensuring effective management and approval of product/process changes for the sites.

* Foster good collaboration on a global scale by participating in cross functional and divisional process improvement initiatives as deemed necessary to support the QMS. Support new business initiatives from a QMS maintenance.

* Understands and has knowledge of system integrations and contributes to development & generation of system requirements on a high level.

* Ensure the updating of monthly Quality Assurance KPIs on all key quality system related performance indicators.

* Supports sites' continued accreditation to all regulatory bodies, supports sites in all internal and external audit programmes.

* Develop Strategy for their Area together with the division and Leader and deploys the Strategy.

Skills & Experience Required:

* Degree or equivalent qualification in engineering, scientific or technical subject

* 6 + years of relevant experience - ideally in Medical Device Manufacturing

* Experience working to FDA QSR, ISO 13485, and the MDD (93/42/EEC)

* Proven experience of growing & leading cross functional teams, ideally across multiple sites

* Demonstrated project management skills

Salary: £55,000 - £65,000

Sthree UK is acting as an Employment Agency in relation to this vacancy.