Overview

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Director of Quality Management Medical (m/f/d)

Vollzeit
Kreisstraße 16, 33790 Halle (Westfalen), Deutschland
Mit Leitungsfunktion
30.01.24

Coveris Flexibles Deutschland GmbH
Coveris is a leading European packaging company that manufactures flexible and sustainable packaging solutions. Our product range includes packaging solutions for sterile barrier systems that have been designed to suit every sterilization process. Products made from Tyvek®, Medical grade Paper, foil and film laminations offer perfect protection for high value sterilized Pharma Products and Medical Devices. Our packaging materials are manufactured in ISO Class 7 and 8 cleanrooms in Germany. The manufacturing plants are ISO 13485 certified and work according to ISO 11607. To improve our quality levels & service and to further improve patient safety, we are hiring a:
Director of Quality Management Medical (m/f/d)

Main Task
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

Required
Bachelor’s or Master’s degree, preferably in engineering or technical discipline
Willingness to travel approximately 25% of the time time (between Halle-NRW and Rohrdorf (Rosenheim)
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
Expert working knowledge of ISO 13495, ISO 11607, ISO 149702 , GMP and MDR

Lean Six Sigma certification preferred
Excellent analytical and statistical skills
S trong decision maker

Strong verbal and written communication skills in both German and Englisch
P erformance driven

F ocus on structured, cost-oriented approach & hands on mentality

We Offer
International career opportunities – 30 locations worldwide
Company car
Hybrid working; Home office
Excellent (internal) training and development
Corporate Events such as Christmas parties, summer parties, joint participation in sporting events
30 days vacation per year
Financial benefits
Company retirement scheme with employer contribution
Bike leasing
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

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