Hans S. - interim Manager & Medical Device Expert

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Zürich, Switzerland

Experience

Jan 2024 - Dec 2024

1 year

Medical Device Product Development Consultant

Hans Spichiger Business Excellence Services GmbH

Medical Device product development, supply-chain and regulatory set-up, with regard to a medical device re-engineering/ launch and manufacturing.

Jan 2023 - Dec 2024

2 years

Project Troubleshooter and Customer Care Consultant

Hans Spichiger Business Excellence Services GmbH

Project trouble shooter & customer care, in the European aerospace industry, within the field of precision optics systems manufacturing.
Project Risk- & Validation-Management including Software-Validation.

Jan 2022 - Dec 2022

1 year

Interim Head of QM

Hans Spichiger Business Excellence Services GmbH

Interim Head of QM in Aluminum-foil deep drawing process improvement.
People- and international Nespresso Supplier Quality Management.

Jan 2022 - Dec 2022

1 year

Validation Management Consultant

Hans Spichiger Business Excellence Services GmbH

Validation (FMEA, IQ OQ; PQ) Management, assigned with the Design- & Process Risk Assessment of complex electrical (IEC60601-1) mechatronics robots for MDR-approval following ISO 14971.

Jan 2021 - Dec 2022

2 years

Consultant for Design & Implementation Support (Cytiva Cell Therapy Project)

Hans Spichiger Business Excellence Services GmbH

Cytiva Cell Therapy greenfield project; assigned with Design- & Implementation-Support of a Certification-, Validation-, GMP-Commissioning-Strategy, for the technical Infrastructure, e.g., clean rooms.

Jan 2020 - Dec 2021

2 years

Denmark

Interim QA Leader

Hans Spichiger Business Excellence Services GmbH

Interim QA-Leader in Denmark, assigned with the Software release, Manufacturing and Distribution of Class IIb Laser equipment for Candela, including international Notified Body- & Manufacturing- Transfer Project.

Jan 2020 - Dec 2020

1 year

Germany

Quality Support and Interim Quality Management Consultant

Hans Spichiger Business Excellence Services GmbH

Quality Support and Interim Quality Management for a manufacturer in the IVD test equipment supply chain and e.g. dialysis supplies in Bavaria.

Jan 2018 - Dec 2020

3 years

Expert/SME in Q-Management and Q-Engineering

Hans Spichiger Business Excellence Services GmbH

Expert/SME in the Q-Management/ Q-Engineering for Orthopedic- and Arthroplasty Device- and tool-production: Turning, milling, cleaning, surface treatment and sterile packaging.

Jan 2017 - Dec 2017

1 year

Consultant for MDSAP Preparation Support and Mock-Audit Coaching

Hans Spichiger Business Excellence Services GmbH

MDSAP Preparation Support and Mock-Audit Coaching.

Jan 2017 - Dec 2017

1 year

Consultant for Product Development Process Re-Engineering (Medela)

Hans Spichiger Business Excellence Services GmbH

Re-Engineering of the Medela Product Development Process, regarding cGMP 21CFR820.30/ ISO 13485:2016 and MDR Design Control requirements, for Soft- & Hardware-Design regarding Class IIb pumps.

Jan 2016 - Present

10 years

Zürich, Switzerland

Free Auditor

Hans Spichiger Business Excellence Services GmbH

Working for various accredited organizations as a freelance auditor, regarding systems according to ISO 13485 and ISO 9001.

Jan 2016 - Dec 2017

2 years

Consultant for DHF Review (Orthopedic Implants)

Hans Spichiger Business Excellence Services GmbH

Orthopedic- and arthroplasties Implants Design History File (DHF) review regarding compliance to 21 CFR 820.30 Design Control requirements.

Jan 2016 - Dec 2016

1 year

Interim Senior QE Expert / Risk & Change-Management Expert

Hans Spichiger Business Excellence Services GmbH

Interim Sen. QE-Expert for Maquet Extracorporeal Circulation Devices (e.g. Oxygenator) manufacturing as e.g., ISO 14971 Risk- & Change-Management Expert in a Roche CAPA remediation & compliance Project, of IVD Blood Analyzers/gas sensor production (IVD).

Jan 2015 - Dec 2015

1 year

Design Control Consultant (Novartis Project)

Hans Spichiger Business Excellence Services GmbH

Assigned by Novartis with Design Control for a new parenteral drug delivery system.
Manufacturability Assessments during the design evaluation.
Assessing of potential plastic injection molding and/ or high-volume assembly contractors in Europe and the US.

Jan 2014 - Dec 2014

1 year

Auditor and Process Validation Consultant (Zimmer Project)

Hans Spichiger Business Excellence Services GmbH

Assessing/ auditing (orthopedic- and arthroplasties device) metallurgy process validation (IQ/OQ/PQ) of multiple potential new as well as existing Zimmer contract manufacturers around Europe for FDA audit redness.

Jan 2013 - Dec 2014

2 years

Subject Matter Expert (Depuy-Synthes Project)

Hans Spichiger Business Excellence Services GmbH

Depuy-Synthes Subject Matter Expert (SME).
CAPA- 8D-Process reengineering and setting in place/ trained new EtQ software tools.
Coaching of 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.

Jan 2012 - Dec 2013

2 years

QA/RA Manager

Sias AG

Engagement at Sias AG, as QA/RA Manager for “in Vitro Diagnostics” (IVD) liquid handling robots’ manufacturing.
Lead a small team for electrical safety CE/ CB-Scheme product approvals.
QMS, Change-, and CAPA-Management.

Jan 2011 - Dec 2012

2 years

Site Quality Manager

Medtronic

Engagement as Medtronic Site Quality Manager for Drug Eluting Balloon- & Nitinol Stent-Catheter manufacturing.
Quality Operations including Q-Engineering & -Control.
Leading 15 direct and indirect reports.

Jan 2010 - Present

16 years

Zürich, Switzerland

Interim manager, consultant, facilitator

Hans Spichiger Business Excellence Services GmbH

Project Management with focus on trouble shooting & customer care and/or Product development/reengineering; Regulatory-Management.
Supply-Chain-; Risk- and Quality-Management; People-Management.
Experienced within Medical Device; Aerospace; Packaging; small- & large equipment; optical- & electrical-systems; metal & plastics.

Jan 2009 - Dec 2010

2 years

Consultant

Business Excellence Services

Supporting quality initiatives in Medical Device Industry.
Assessments and Audits for Manufacturers as well as on suppliers’ sites as a consultant of newly set up own company “Business Excellence Services”.

Jan 2007 - Dec 2009

3 years

Nidau, Switzerland

Head of Quality Management

forteq Healthcare

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 extension, including the Qualification and Validation management.
Responsible for the Quality Assurance and - Control department, including product release as well as for 20 direct- and indirect-reports.
Management system-, Document-, Compliance-, CAPA-, Change- and Complaint responsibility according to US- and EU-Medical-Device- & GMP-Regulations.

Jan 2003 - Dec 2005

3 years

Au, Switzerland

Quality Manager

ESCATEC

Quality Manager including HSE responsibilities for the internationally active medical devices and measurement systems Electronics Contract PCB-Manufacturer (ISO 9001; 13485; 14001).

Jan 2001 - Dec 2002

2 years

Küsnacht, Switzerland

Consultant; Lecturer

Dr. Schnetzer Consulting

Consultant for methodical process design and -management in IT departments of leading Swiss 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 Engineering.”

Jan 1999 - Dec 2001

3 years

Horgen, Switzerland

Quality Manager

Schweiter Technologies

Quality Manager in the international logistics network of this machinery manufacturer.
People management and strategic outsourcing projects.

Jan 1999 - Dec 2001

3 years

Zürich, Switzerland

Business Organizer

Telekurs-Payserv

Business Organizer in the largest computer center owned by the Swiss banks.

Jan 1994 - Dec 1999

6 years

Zürich, Switzerland

ABB Customer Focus Manager (Quality- and Environmental Management, Security, Safety, Training)

ABB

Project management in the setting up of management systems (ISO 9001; 14001, Health & Safety), in three languages at 14 sites.
Leading Project Manager for certification, according to ISO standards.
Auditing and Assessments according to EFQM within the ABB Group.
Project Management Trainer for a group of 80 Project Manager’s.
Managing with support of 7 assistants, the training and development around 120 apprentices at 14 locations throughout Switzerland.

Jan 1986 - Dec 1994

9 years

Wikon, Switzerland

Project Manager

Hunkeler Entsorgungssysteme

Build-up and management of a team executing the electrical engineering for the construction of bulk goods installations.
CE-documentation of complex shredding systems in a waste incineration plants.
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 design and development of the equipment control.

Jan 1977 - Dec 1986

10 years

Aarburg, Switzerland