up to £60,000 per annum DOE
Purpose of the role:
Responsible for oversight of all activities related to the management and maintenance the Quality Management System (QMS) and Quality Manual. Ensure that the QMS reflects actual activities and business needs and Standard Operating Procedures (SOP’s) and Work Instructions (WI’s) cover all business processes.
Ensure the QMS is developed, maintained and implemented to requirements of ISO13485:2016
Ensure that the team fully understand and appreciate the importance of adhering to the quality policy.
Manage the internal inspection team to ensure that they work efficiently and effectively, inspect products received from our suppliers to the required specifications.
Responsible for and manage the QA Team for the final sign off and release of products.
Maintain a process of regular internal QMS Audit and on-site supplier audits in line with the QMS Audit Plan.
Represent the company in external audits including certification/recertification audits with notified bodies.
Manage the Non Conformity Reporting process (NCR). Ensure current suppliers meet all regulatory and quality standards.
Manage the Corrective and Preventative Action Plan (CAPA) process via periodic review with CAPA holders.
Manage Document Control and Risk Management processes.
Work in collaboration with the regulatory manager to maintain good relationships and accreditation to all pertinent regulatory and notified bodies.
Knowledge skills and experience:
Must have knowledge and proven track record / credentials in Quality Management in a healthcare company operating within European and ideally the US market.
Have a clear understanding of ISO 13485:2016.
Must have excellent I.T. skills to maintain various databases and present quality data in the form of departmental reports
Working within a medical device/pharmaceutical company
For more information please contact email@example.com or call 01223 463 300
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