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

View job hereDirector of Quality Management Medical (m / f / d)VollzeitKreisstraße 16, 33790 Halle (Westfalen), DeutschlandMit Leitungsfunktion30.

01.24Coveris Flexibles Deutschland GmbHCoveris 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 standardsDevelop, review and maintain quality policies in collaboration with corporate qualityGuide, train and manage the activities of the quality and validation teamsResponsible for managing the quality management systemsManage corrective and preventive action teams and develop individual corrective and preventive action plans and systemsReview Corporate and ISO Quality Audit Reports and prepares appropriate corrective action responsesEstablish systems to document and maintain process validation and maintaining compliance.

Responsible for the performance management and career development of direct reports and their subordinatesPrioritize quality engineering projects and assignments for completion by the appropriate QA personnelEstablish 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 reductionKeep the site and corporate leadership teams informed about quality-related problems and issuesEnsure compliance with Good Manufacturing Practices (GMP and ISO), safety policies, and good housekeeping and that safety and hazard practices are understood and followedWork to assure Quality Assurance requirements are maintainedWork to assure regulatory compliance with pertinent outside agenciesResponsible for the investigation of product and process quality and manufacturing issuesRequired Bachelor's or Master's degree, preferably in engineering or technical disciplineWillingness to travel approximately 25% of the time time (between Halle-NRW and Rohrdorf (Rosenheim)Quality Management certification of Notified Body10+ years' experience in quality and compliance with progressive and extensive experience in medical device quality managementExperience with medical devices & packaging and managing a comprehensive quality teamKnowledge of all phases of project managementExpert working knowledge of ISO 13495, ISO 11607, ISO 149702, GMP and MDRLean Six Sigma certification preferredExcellent analytical and statistical skillsStrong decision makerStrong verbal and written communication skills in both German and EnglischPerformance drivenFocus on structured, cost-oriented approach & hands on mentalityWe OfferInternational career opportunities - 30 locations worldwideCompany carHybrid working;

Home officeExcellent (internal) training and developmentCorporate Events such as Christmas parties, summer parties, joint participation in sporting events30 days vacation per yearFinancial benefitsCompany retirement scheme with employer contributionBike leasingDiscounts 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 connectionsOnline bewerbenImpressum DatenschutzerklärungPowered by softgarden