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Quality System Manager
Published on: Nov 1, 2024
Country: United Kingdom
Location: Dartford
Job Category: Quality
Employment type: Regular Full Time
Summary:
In this key role, you will manage and maintain the Supplier Management program including supplier approval, supplier audits, re-evaluation and non-conformances. You will also manage, coordinate and participate in both internal and external site audits, support the accuracy and relevance of the site Quality Manual and Quality Plans as well as provide support to the Quality Assurance Team with a number of activities.
Responsibilities:
* Manage and maintain the site Supplier Management program including Supplier Approval, Supplier audits, Supplier re-evaluation and Supplier non-conformances.
* Support SCFT (Supplier Cross Functional Team) activities to ensure issues are actioned and material is available to use in a timely manner.
* Coordinate and monitor completion of change notifications received from Suppliers.
* Maintain incoming material Technical Specifications.
* Manage, coordinate and participate in both Internal and External site audits as required.
* Support the accuracy and relevance of the site Quality Manual and Quality Plans as required by relevant procedures.
* Support the Quality Assurance department in various aspects of the site Quality System including NC and CAPA, Change Management, Risk Management, Post Market programme, Audit, QS Documentation, and Training.
* Ensure all relevant quality metrics are compiled and reported when required.
* Coordinate Management Reviews and ensure the critical aspects of the Quality System are highlighted and addressed. Ensure meeting data, minutes and information for Management Review is collated and distributed in a timely manner.
* Through the effective management of the Quality Systems group, ensure that the plant meets the quality requirements of its customers, Corporate, ISO, Auditors, IVDD/IVDR and other external agencies.
* Approach the role in a flexible manner and be prepared to adapt to requirements outside of the immediate role that are essential to the organisation.
Experience, Qualifications and Skill Requirements:
* Sound knowledge of ISO and 3-5 years of experience in an ISO quality-controlled environment in commercial health care product manufacture is essential.
* IVDD/IVDR knowledge is beneficial.
* Problem solving techniques; data analysis skills and basic quality knowledge.
* Accountability
* Highly motivated and proactive.
* Solution focused.
* Ability to form effective working relationships.
* Excellent attention to detail.
* Ability to adapt to changing priorities.
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