
Marcel Hinder
Fähigkeiten und Kenntnisse
Werdegang
Berufserfahrung von Marcel Hinder
- Bis heute 1 Jahr und 6 Monate, seit Dez. 2023
Global Director Design Quality Assurance
Sonova Group
Leading the Design Quality Assurance Organization which consists of the following teams: - Design Quality Assurance located at HQ Stäfa, Switzerland - Design Quality Assurance at Kitchen, Canada - Global Risk Management for Medical Devices - Global Service Quality Assurance
- Bis heute 11 Jahre und 1 Monat, seit Mai 2014
Lecturer
SAQ-QUALICON AG
Design Control (ISO 13485:2016, MDR 2017/745, QSR 820.30) • Design Input, Output, V&V, Reviews • Risk Management (ISO 14971) / Usability (IEC 62366) • Statistical sampling for Design V&V • Traceability • Design Transfer (DHF/DMR/DHR) / Changes • Design History File (DHF) Design for Six Sigma (DfSS): • SIPOC • Quality Function Deployment (QFD) • TRIZ (Methodology for Creative Problem Solving) • Six Sigma • Lifetime analysis • Statistical Tolerancing • Statistical methods • Value Stream Mapping (VSM)
- 1 Jahr und 3 Monate, Sep. 2022 - Nov. 2023
Global Director QA Excellence
Mölnlycke Health Care AG
- 3 Jahre und 4 Monate, Mai 2019 - Aug. 2022
Assoc Director Quality Engineering
Zimmer Biomet
Heading a team of 43 quality engineering specialists Leading of four quality departments: • Quality Engineering • Metrology Engineering • Production Control & Router Auditing • Final Release & Shipment Approval SME in MDSAP (FDA, ANVISA, TGA, Health Canada, MHLW), BSi (EU) and roving audits MDR 2017/745 implementation Implementation of MES system QA for Design / Process / Transfers Corporate expert for statistical advices and trainings Strategic projects (Lean Quality, Six Sigma, QFD, Class A, OPEX)
- 9 Jahre und 5 Monate, Aug. 2010 - Dez. 2019
Department Manager, Quality Engineering
Zimmer Biomet
• Leading of two quality departments (Design and Production) • Heading a team of 13 quality engineers • Lead of the Lean Quality Initiative (e.g. Q-Circle) • Responsibility for QA activities (NPI, Transfers, PME) • Corporate Procedure for statistical techniques • Review and release of all site specific process and CSV validation activities (IQ,OQ,PQ) • Member of Lean Six Sigma and Business Excellence (BEX) committee • QA lead for implementation of MES system • Support, coordination and lead of CAPAs
- 1 Jahr und 1 Monat, Juli 2009 - Juli 2010
Assistant Department Manager / Team Leader Quality Engineering Reconstructive
Zimmer Biomet
• In charge of all risk based quality inspection planning activities for the reconstructive business • Creation and training of local and global (G)SOP’s • Member of the lean six sigma committee • Heading a team of 3 quality engineering specialists (Recon: hip, knee and upper extremities)
- 4 Jahre und 5 Monate, Feb. 2005 - Juni 2009
Global Project Leader / Development Engineer Hip
Zimmer Biomet
• Leading, planning and budgeting of global development projects (Fitmore Hip Stem, Global Case Design) • Project Team EU Up-Classification (Class IIb to class III devices (2007/47/EC)) • Development of new Hip Implant Systems (MMC Cup, Allofit Alloclassic Line Extension) • Regulary meetings with designing surgeons • Member of Design Control (QSR 820.30) / Risk Management (ISO 14971) Committee • Support of PMS activities Patent: WO 2007039647: Date of publication: 12.April 2007
- 2 Jahre und 10 Monate, Apr. 2002 - Jan. 2005
Development Engineer
Dividella Pharma Packaging Technology (Körber Group)
• Development of customized packaging systems used in the pharmaceutical industry • Creation of 3D CAD models, drawings and production specifications • Supplier relationship management (SRM) • Person in charge for two apprentices
Ausbildung von Marcel Hinder
- 2 Jahre und 8 Monate, März 2011 - Okt. 2013
Master Quality Leadership
University of Applied Sciences in Business Administration Zürich
- Consulting & Communication (e.g. Harvard Concept) - Non Violent Communication - Business Excellence (EFQM), ISO 9001:2008, Audits - Continuous Improvement (DoE, Six Sigma) - Leadership & Strategy (Accounting & Controlling) - Integrated Systems & Compliance
- 2 Jahre und 6 Monate, Juni 2004 - Nov. 2006
Master Business Administration and Engineering
University of Applied Sciences FHO
• Strategic / operative marketing, price selling strategies (marketing mix), portfolio analysis (SWOT) • Accounting, capital budgeting, controlling (e.g. discounted cash flow, IRR, NPV, ROI) • Risk Management • Management, organization and logistic • Project Management, Total Quality Management (TQM), Innovation Management, presentation techniques Master thesis: „Quality Function Deployment (QFD) – Development of a global instrument case for the medical company Zimmer Inc.“
- 1998 - 2001
Systems Engineering FH
Interstate University of Applied Sciences of Technology Buchs
• Product engineering, mechanical design, structural/dynamic analysis, fatigue-strength finite element analysis • Manufacturing, automation, supply chain, statistic (DoE) • Quality testing and manufacturing measurement, design methods and dimensional measurement • Material science Diploma thesis: “Needle free injection system for diabetics” Major achievement: Patent registration DE10160393: Date of publication: 18. June 2003
Sprachen
Deutsch
Muttersprache
Englisch
Fließend
Französisch
Grundlagen
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