AX-7288 Medical Device Quality Manager
Opportunity for an experienced Quality Manager to have oversight of all Medical Device Quality systems within an exciting Biopharma Organisation. Utilising matrix management design, you’ll develop and maintain a medical device compliant Quality Management system that is adaptable to changing business needs.
Based to the West of London
Strong Medical Device and Pharma Portfolio
In the role of Medical Device Quality Manager, you’ll provide oversight of current and evolving Medical Device regulatory requirements to ensure the MDQMS remains current. Maintain up to date knowledge of laws and regulations, keeping abreast of recent changes relating to medical device standards, practices and regulations.
Report to senior management through management review on the performance of the Medical Device quality management system and any need for improvement using KPIs. Maintain awareness of customer requirements throughout the organization and ensure these are supported by the MDQMS, ensuring those processes needed for the Medical Device quality management system are established, implemented and maintained.
Development of globally harmonised processes for critical Medical Device business processes.
Design, development and continuous review of the MDQMS to ensure its continues to meet business and regulatory expectations
Perform and executes audits in compliance with ISO 13485, Medical Device Directive/Regulation as applicable.
QUALIFICATIONS / EXPERIENCE REQUIRED:
Experience at a managerial level in a small to medium sized Medical Device organisation.
An engineering degree or equivalent
Excellent Knowledge and proven application of the medical device requirements
Strong analytical skills with respect to organisational patterns, to professional and personal interactions between staff and to documented evidence.
Experience of setting up and managing MDQMS
Medical Device auditing experience
Before you apply for this position it is vital that you are in possession of an EU or UK passport or relevant visa to work without restrictions in the UK.
For a confidential discussion please telephone Sukhveer Gill at AXESS Limited on 020 8560 2300 quoting reference 7288.
To apply, please click the APPLY ONLINE button.
Medical Device QA Manager / UK Medical Device Quality Manager / Device QA Manager / Bucks / Berks / MEDICAL DEVICE QUALITY MANAGER / QA Manager
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