Bernd Dr's Email Addresses & Phone Numbers

📖 Summary

Experience: 15yrs experience within multiple global players in the Medical Device Industry, 2yrs experience within BioTech Start-Up Goals: International Sr Leadership role in Quality or Operations at a global player Specialities: Quality Management, Manufacturing Operations, global Program and Project Management, manufacturing transfers, design control & transfer to production, process simplification, human error reduction, compliance issue resolution, site turnaround, cultural transformation, inspection readiness, site closure, operatinal excellenceDirector Quality, Swiss Medtronic Operation @ define 5yrs quality strategy of the site, improve succession planning/ leadership pipeline, global process harmonization, increase site inspection readiness, cultural transformation From September 2014 to Present (1 Jahr 4 Monate) Director Quality & Compliance @ Aug2013-Sep2013: site turnaround (compliance issues resolution), rebuild Quality Organization, establish Quality Organization as a valued service provider, Management Representative, inspection & inspection readiness (FDA, TUV), responsibility for all operational quality functions at a site (including Ops QE, QC, MQA, SQA, Micro/Sterilization, Regulatory Compliance, QS and R&D QA) as of Oct2013: plan and execute site closure From August 2012 to August 2014 (2 Jahre 1 Monat) SchweizManager Strategic Quality @ Program Quality Manager and PDMRB* Quality Representative for large scale, global strategic operations programs; control and coordinate simplification-, human error reduction implementation activities related to manufacturing processes across 5 international manufacturing sites From März 2011 to Juli 2012 (1 Jahr 5 Monate) Divisional QA Program Manager @ lead 8 global projects which aim for Quality System simplifications and human error reductions (global benchmarking across multiple manufacturing sites, introduction of best-in-class processes and meaningful scorecards, process monitoring, simplified SOPs (Standard Operating Procedures), introduction of picture guides and different learning approach) From Oktober 2009 to Juni 2011 (1 Jahr 9 Monate) QA Principle Project Manager @ lead 1 global project which aim for Quality System simplifications and human error reductions (global benchmarking across multiple manufacturing sites, introduction of best-in-class processes and meaningful scorecards, process monitoring, simplified SOPs (Standard Operating Procedures), introduction of picture guides and different learning approach) From Oktober 2008 to September 2009 (1 Jahr) Quality Control Manager @ Product Release & Release Testing (review and approval of Investigations, Nonconformances, CAPA, Risk Evaluations); Environmental Monitoring Program; From Mai 2006 to September 2008 (2 Jahre 5 Monate) Transfer Project Manager @ manufacturing transfer of 8 components and/or final products across international manufacturing sites (Manufacturing Operations) From Februar 2003 to April 2006 (3 Jahre 3 Monate) Technical Leader @ technical support of 6 different diagnostic assays for the detection of Hepatitis-/ Retroviruses (Manufacturing Operations) From April 2001 to Januar 2003 (1 Jahr 10 Monate) Molecular Biologist @ synthetic gene development From Februar 2000 to März 2001 (1 Jahr 2 Monate) IRCA QMS Lead Auditor, ISO 9000/ 9001, IRCA QMS Lead Auditor @ TÜV Rheinland From 2014 to 2014 Sicherheitsbeauftragter (nach §30 Medizinproduktegesetz) @ TÜV Süd From 2014 to 2014 Medizinprodukteberater (nach §31 Medizinproduktegesetz) @ TÜV Süd From 2014 to 2014 Certified Quality Manager, Quality Management @ Chartered Institute of Quality; London From 2007 to 2008 Dr, Chemistry, Molecular Biology @ University of Regensburg From 1990 to 2000 Bachelor, Chemistry, Biochemistry @ University of Cologne From 1987 to 1990 Bernd Dr is skilled in: Quality System, Medical Devices, Quality Management, CAPA, Quality Assurance, FDA, GMP, Sop, Operations Management