Quality Manager

Zenopa Recruitment are partnering with Abbott Rapid Diagnostics to assist them hiring a new Quality Manager.

TITLE - Quality Manager
REMIT - Ensuring Quality System awareness and compliance of new and revised quality documents and regulations
PRODUCTS - Rapid Diagnostics
LOCATION - Maidenhead (2 days per week)

The Quality Manager will have 1 direct report and will ensure Quality System awareness and compliance of new and revised quality documents and regulations that affect the assigned area of responsibility.

Key responsibilities as Quality Manager:
· Plan and conduct internal audits to verify the effectiveness of the management system
· Prepare/ coordinate external audits.
· Perform supplier audits as required.
· Support/provide training to the organization about the ADD Quality System.
· Ensure QS record keeping, document control, Warehousing, QH, Supplier/ Distributor evaluation/ monitoring, CAPA management follow up and ensure timely closure.
· Coordinate Field Communications at the Region.
· Ensure availability of org charts (including LSME if required) and job descriptions.
· Ensure the setting and tracking of the Training Plan for all positions.

Requirements
· Scientific background (i.e. Lab Technician, Biology, Chemistry, Pharmacy, M.D.) is preferred. Other education (i.e. business, engineer) is acceptable if strong experience in a similar manager position.
· Quality Assurance experience in a commercial affiliate in the IVD/ MD/ pharmaceutical industry is preferred
· Regulatory Affairs, Customer Service or any other commercial affiliate function experience in the diagnostic/ medical device/ pharmaceutical industry
· Product and market environment knowledge preferred
· Management skills and leadership competencies

Apply now to find out more about this exciting role.

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