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Coveris Flexibles Deutschland GmbH

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Director of Quality Management Medical (m/f/d)
Halle (Westfalen)
Aktualität: 14.02.2024


14.02.2024, Halle - Coveris Flexibles Deutschland GmbH
Halle (Westfalen)
Director of Quality Management Medical (m/f/d)
Analyze and harmonize internal quality systems and associated data to assure adherence to QSRs, ISO, and other international standards, corporate quality standards, and Divisional and Facility quality standards Develop, review and maintain quality policies in collaboration with corporate quality Guide , train and manage the activities of the quality and validation teams Responsible for managing the quality management systems Manage corrective and preventive action teams and develop individual corrective and preventive action plans and systems Review Corporate and ISO Quality Audit Reports and prepares appropriate corrective action responses Establish systems to document and maintain process validation and maintaining compliance. Responsible for the performance management and career development of direct reports and their subordinates Prioritize quality engineering projects and assignments for completion by the appropriate QA personnel Establish systems to document and maintain process validation and drawing compliance. Perform periodic complaint trend analysis and makes recommendations and reviews associated action plans for complaint reduction Keep the site and corporate leadership teams informed about quality-related problems and issues Ensure compliance with Good Manufacturing Practices (GMP and ISO), safety policies, and good housekeeping and that safety and hazard practices are understood and followed Work to assure Quality Assurance requirements are maintained Work to assure regulatory compliance with pertinent outside agencies Responsible for the investigation of product and process quality and manufacturing issues P erformance driven Discounts from various partners as well as shopping advantages with numerous famous brands via «corporate benefits» (in the areas of sports, events, mobile communications, clothing...) Free and plenty available employee parking space and good public transport connections
Bachelor's or Master's degree, preferably in engineering or technical discipline Quality Management certification of Notified Body 10+ years' experience in quality and compliance with progressive and extensive experience in medical device quality management Experience with medical devices & packaging and managing a comprehensive quality team Knowledge of all phases of project management Lean Six Sigma certification preferred Excellent analytical and statistical skills Strong verbal and written communication skills in both German and Englisch F ocus on structured, cost-oriented approach & hands on mentality Excellent (internal) training and development