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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 13485, ISO 11607, ISO 14972, GMP and MDR
  • Lean Six Sigma certification preferred
  • Excellent analytical and statistical skills
  • Strong decision maker
  • Strong verbal and written communication skills in both German and Englisch
  • Performance driven
  • Focus 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