philip cantzler

team coordinator global device management

About

Quality Assurance (2 Production Centers, 1 Design Center) Quality Control (2 Production Centers) Process Engineering (Dental Implants, NiTinol Stents, Stent Catheters) Process Engineering (CNC, Surface Treatment, Final Cleaning, Assembly, Packaging, Sterilization) Process Engineering (Cleanroom processing , Highly Purified Water, Cleanrooms, Media, Etching, Surface Coating) Production Line Layouts, Building Layouts Building Reconstruction projects Process Validation, Validation Masterplanning Equipment Qualification, Calibration, Maintenance Change Management CAPA FMEA Lean Production Management of Process Engineering Teams Management of QC Teams Project Management Design to Manufacturing Transition Manufacturing Technology Transfer Process Hygiene Monitoring Auditor (First & Second Party)

Country

germany

City

frankfurt am main

Industry

medical devices

Skill

iso 13485, capa, quality management, technologietransfer, process validation, fmea, fertigung, iso 9001, r&d, schlanke produktion, fda, quality assurance dental implants, quality control dental implants, dental implants, mdsap, mdr, cfr 820, project management, change control, lean manufacturing, stents, process engineering mechanical and chemical surface treatment, process engineering cleanroom processing, projekte design to manufacturing transition, process hygiene monitoring, din en iso 13485, din en iso 9001, manufacturing technology transfer, validation masterplanning

Experience

team coordinator global device management

roche

2019-1 - Present · 7 yrs 9 mos

team coordinator global device management

manager manufacturing engineering

angiomed gmbh

2008-1 - 2010-3 · 2 yrs 3 mos

manager oberflÃ chentechnologie

dentsply friadent

2000-7 - 2004-6 · 4 yrs

product management biomaterials

dentsply friadent

1997-7 - 2000-6 · 3 yrs

manager

ingenieurbüro philip cantzler

2010-4 - 2010-6 · 3 mos

* Freelancer * FDA audit preparation * Process validation consulting

senior manager quality assurance

dentsply implants

2013-1 - Present · 13 yrs 9 mos

* Execution of First and Second Party audits. * Regulatory compliance, preparation, training, hosting of 3rd Party audits (EG-Certification, ISO-Certification, ANVISA, NCED, MFDS, GCC, FDA, MDSAP) * ISO 13485:2016, MDD, CFR 820, ISO 9001. * Supplier qualification, PPAP. * R&D design control, project reviews and approvals. * Process validation review and approval. * Management of 2 QC teams at 2 production sites. * CAPA, Root Cause Analysis, SPC, Document Control.

manager process technology

dentsply friadent

2004-7 - 2007-12 · 3 yrs 6 mos

* Layout, planning, project management of conversion of CNC-manufacturing building into cleanroom facility. * Concept, process engineering, installation and validation of new final cleaning lines for dental implants. * Process engineering for new implant surface treatment process. * Management of Process Engineering team.