Manager, Consultant, Coach, Auditor and Free-lancer with own Company
(ISO9001, ISO13485 & ISO14971 Risk-Management - MDR & CFR820 - MDSAP) Orthopaedic- & Arthroplasty Implants– Extracorporeal Circulation Devices (Heart-Lunge-Machines) Drug Delivery Systems - IVD Sensors - Electronics Assembling – Packaging in Cleanroom – Sterilization - Validation (IQ/OQ/PQ) Metal Machining Processes & -Refinement as polishing, passivation, coating, cleaning CAPA-Mgm. – Design & Development of Soft- and Hardware in integrated Systems Design-Controls - External- & Internal Audits – Supplier-Management &
Evaluation – Laser Technology QA/RA-Lead(PRRC/ Q-Rep/ QB) Electronics production – Injection Moulding – Testing – Sterilization
PCB – Drug delivery systems - Catheters – Balloons - Stents
IVD Liquid-Handlers – Cleanroom – IQ/OQ/PQ – CE-marking
Electrical Engineering – Project Management – QMS – Leadership
PROJECT HISTORY
01/2010
- 01/2019
Interim Manager, Consultant, Coach and Auditor for Business Excellence Services GmbH, Zürich & Geneve - Switzerland
international assignements in Projects for companies as e.g. Candela, Novartis, Roche, Zimmer, Medela, Getting
01/2013
- 01/2014
Depuy-Synthes Subject Matter Expert (SME for CAPA-; Complaint-; Field Action Management at Head-Quarter)
CAPA process reengineering and sat in place trained new EtQ
software tools. Coaching Project- and Product-Managers in working
through their assigned individual CAPAs. Remediation of global
legacy CAPAs. Supporting the complaint- as well the field action-
(FSCA) Management by new software tools within related CAPAs.
01/2012
- 01/2013
Sias AG
50-250 employees
Pharmaceuticals and medical technology
QA/RA Manager
Diagnostics" (IVD) liquid handling robots' manufacturing. Lead a
small team for electrical safety CE product approvals.
QMS enhancement as well as Change-, and CAPA-Management.
01/2011
- 01/2012
Medtronic-Invatec
50-250 employees
Pharmaceuticals and medical technology
Site Quality Manager
Balloon- & Nitinol Stent-Catheter manufacturing. Quality
Operations including Q-Engineering & -Control.
Leading 15 direct and indirect reports.
01/2009
- 01/2011
Medical Device Industry
< 10 employees
Pharmaceuticals and medical technology
Consultant of Business Excellence Services
Assessments and Audits intern as well as on suppliers' sites as a
Consultant of Business Excellence Services.
01/2007
- 01/2009
forteq Healthcare
50-250 employees
Pharmaceuticals and medical technology
Head of Quality Management
? Head of Quality in the manufacturing of combined medical
devices for GlaxoSmithKline's asthma treatment program.
? Plastic injection, -printing and micro assembling in clean room.
? Clean room and manufacturing extension, including the
Qualification and Validation management.
? Responsible for the Quality Assurance and - Control department
including product release as well as for the Quality system on site.
Leading 20 direct- and indirect-reports.
? Management system-, Document-, Compliance-, CAPA-, Change-
and Complaint responsibility according to US- and EU-Regulations.
01/2003
- 12/2005
ESCATEC
50-250 employees
Industry and mechanical engineering
Quality Manager including HSE
responsibilities for the internationally active medical devices and
measurement systems Electronics Contract Manufacturer for PCB's.
? Entrusted with the company's management systems (certified against
ISO 9001; 13485; 14001), and the BEX process management.
01/2001
- 12/2002
Dr. Schnetzer Consulting
< 10 employees
Banks and financial services
Consultant
? Consultant for methodical process design and -management in
IT departments of important banks and insurance companies.
? Lecturer for Business management as part of after degree studies
e.g. at Kaleidos-AKAD or IFA: "Master of Business Process Engin."
01/1999
- 01/2001
Telekurs-Payserv, Zürich & Schweiter Technologies
50-250 employees
Internet and Information Technology
Quality Manager
machinery company. Including management of the Goods in
Department at the Headquarter and strategic outsourcing projects.
? Business Organizer for the largest computer center of the Swiss banks.
01/1994
- 01/1999
ABB
1000-5000 employees
ABB Customer Focus Manager: includes Business Excellence; QM; QA; Safety-; Environmental-; Security- and Training-Management
(Quality- and Environmental Management, Security, Safety, Training)
? Project management in the setting up of management systems.
(ISO 9001; 14001, Health & Safety), in three languages at 14 sites.
? Certification of several systems, according to ISO standards as the
leading Project Manager.
? Auditing and Assessments according to EFQM within the ABB Group
? Project Management Trainer for the 80 technical Project Manager's
around Switzerland.
? Management of the training and education of 120 apprentices with 7
assistants at 14 sites all over Switzerland.
01/1990
- 01/1994
Hunkeler Entsorgungssysteme
10-50 employees
Industry and mechanical engineering
Project Manager & Electrical Engineering
? Build-up and management of a team executing the electrical
engineering for the construction of bulk goods installations.
? CE-conform documentation of complex industrial plant installations
and organization.
? Execution of extensive customer trainings e.g. in Italy and Geneva
? Validation/ Qualification of huge paper processing equipment in
banks, the printing industry as well as private and public recyclers.
? Project management and roll out of Computer Aided Engineering
(CAE) as well as PLC system application for the equipment control.
01/1977
- 01/1986
CKW, Reiden/ Luzern and Weber & Cie AG
Electrical installations and industrial control technician
for power electronics including vocational baccalaureate.
TIME AND SPATIAL FLEXIBILITY
International experianced: Europe, US, Asia, Africa
Preferred for working in western Europe
OTHER
Experienced Swiss Medical Device Quality Leader and Expert, speaking English, French and German
· Professional Experience: 40 years
· Leadership Experience: 18 years
· Quality Management Experience: 23 years
· Supplier Quality Management Experience: 20 years
· Medical Device Manufacturing Experience: 18 years
· Own Swiss company: in the last 6 years Let me know about your immediate needs as:
For instance, consulting, interim solutions or hands on work in:
Design Control for Product Development – Supplier/CMO Management
Management System adaption – Risk-Assessments/Management
Mergers and Acquisitions GAP-Analysis e.g. DHF/ STED/ Tech-File/ CAPA …
Compliance Management e.g. MDD/ MDR, 21 CFR 820 …
GET IN TOUCH
You can't contact this user because he's on your blacklist.
Thank you for subscribing
You have been successfully subscribed to the freelancermap newsletter.
