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- Manage the Team of two QA Assessors, define their Goals and evaluate their annual performances
- Liaising with internal and external auditors when required and act as lead intenal Auditor
- Coordinate and drive the initiation, investigation and closure of Non-Conformance Report and intra-site Quality Feedback.
- Drive the management of Customer Complaint and Service Non-Conformance
- Support the writing and review of the Operational documentation (SOPs, WIs, ...)
- Supervision, execution and trending of QC checks
- Supervising QA Assessor and identification of appropriate training needs
- Coordinate associated quality processes through the eQMS
- Support data trending
- Support preparation and execution of external audit and certification processes
- Actively identify Continuous Improvements Opportunities inside the Distribution Operations
- Support the maintenance of GMP awareness and Quality Culture on the shopfloor and helping staff to implement Quality Improvements.
- Act as CAPA and change leader for individual CAPA and change control activities
- Involve in risk management activities
- Support identification and management of non-conforming products and coordinate or execute lot blocking and lot tracing activities
- Be part of new product launch, changes and product obsoletion
- Any other duties as directed by QA Management
- min. 4 years' experience within a Quality assurance role
- Experience in the medical device industry or in a regulated quality system
- Team Management
- Good written and verbal communication in English and French
- Organizational skills
- Computer literate, with intermediate skills in the use of Word, Excel, PowerPoint, Outlook and Microsoft Visio
- Ability to work with ERP, WMS and eQMS
- Ability to work effectively either alone or as part of a team.
- Ability to take initiative, autonomous
- Ability to prioritize workload.
- Motivated with good interpersonal and written communication skills to communicate effectively with all levels within the quality department as well as cross functionally within departments at the Liège Distribution Center and other CooperVision distribution sites.
- Knowledge of ISO14971 risk management and change management experience is an asset
- Working knowledge of ISO13485 and MDSAP
QA Coordinator - Herstal, België - CooperCompanies
CooperCompanies
Herstal, België
2 weken geleden
Beschrijving
To coordinate the Quality Assessors and work as part of a team monitoring and managing the Operational area of the Quality System. To ensure staff are working according to documented procedures and requirements, sample and verify order through the QC checks. Identify Continuous Improvement opportunities and support implementation of new procedures, processes or systems.