Head of Quality / Quality Director - Scotland - £75k-85k
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Quality Director / Quality Assurance Director / QA Director / Head of Quality / Head of Quality Assurance / Head of QA
A world leader in Medical Devices is seeking a driven Head of Quality who can hit the ground running and competently lead on Quality Assurance for the business globally.
It is important that the Head of Quality is a hands-on leader and has a passion for developing the skills and management capabilities of their direct reports whilst promoting a culture of high performance.
The role will require you to be able to commute to the office in Scotland. There is a relocation package available for those who require it.
Overview of key responsibilities:
* Management of QA Compliance processes and associated personnel
* Development and maintenance of a process based QMS,
* Maintenance and development of robust and compliant CAPA, Complaint, NCR, Internal Audit and Supplier Management processes
* Development of materials for Induction and Annual cGMP training programmes for all new and existing personnel.
* Development of a team of trained Internal Auditors within the facility ensuring timely and effective execution of the Internal Audit programme
* Development of effective internal and external customer relationships to ensure quality and regulatory compliance for the business
Qualifications and experience required:
* 10-15 years of experience in Quality Management Systems in a similar role within a medical device environment
* Degree in Scientific/Engineering or related Degree. Post graduate qualification advantageous
* Experience of hosting regulatory and customer audits, including Notified Body audits and FDA Inspections
* Working experience of MDD for devices up to class III
* Thorough knowledge of regulatory standards, Quality Management Systems and global regulations for medical devices including FDA
* Six Sigma qualified
* Prior experience in management of departmental budgets