Quality Manager Supplier

C U R R I C U L U M V I T A E

PERSONAL DATA

Stefan-Ioan Teodoropol

Drusbergstrasse 1B +41-78-888-**-** (Mobile)

CH-8820 Wädenswil, ZH **********.******@*****.***

KEY EXPERTISE

** *** ***, ** 2017/745, cGMP

Certified Lead-Auditor ISO 13485, Certified 6-sigma, ISO14971, CAPA, FMEA

GHTF/SG3/N99-10:2004, Verification-Validation-Qualification, IQ-OQ-PQ

Global QMS design, implementation, compliance & maintenance

Change Management Process (Process/Product) implementation

Risk Management, New Product Introduction, FDA Inspection Support

FDA Audit preparation (Gap analysis, Requirements gathering)

Supplier Evaluation & Auditing, Quality Review Board

Oncology, Radiation Therapy, X-Ray Equipment

Medical Device Single Audit Program (MDSAP), ISO13485:2016 transition

Technical Files compliance/analysis (CE submission)

Device Master Record & Device History Record review & maintenance

STRENGTHS

Strategic, disciplined, focused, analytical, hands-on, effective problem-solver

Self-starter, communicative, flexible, convinced team-player, influencer

Multicultural experience, excellent ability in working in cross-functional teams

Standard implementation: ISO 9001, ISO11607, ISO 13485, ISO 14971, 21 CFR 820, EU 2017/745, GHTF/SG3/N99-10:2004, GTHF/SG4/N84:2010

EMPLOYMENT HISTORY

09. 2020 - 09. 2022 BD-Wangs (Straub Medical AG) Supplier Quality

• Supplier Gap Analysis - Review of existing supplier files and Supplier Quality

procedures to assess adherence with corporate and regulatory requirements

• Drive gap analysis & perform various remediation activities

• Transfer of Supplier Files into a standardized BD electronic repository

• Transition Straub Medical Approved Supplier List (ASL) into a standardized BD

• Acting as a lead Supplier Auditor (conducted 20 supplier audits in the last year)

• SCAR & CAPA process owner

• Conducting supplier re-approval activities in accordance with governing

procedures

02. 2020 – 08.2020 LABORIE MEDICAL TECHNOLOGIES Quality Assurance

• Timely and effective closure of outstanding Audit CAPA’s and associated action items including creation of procedure and work instruction revisions, implementation of process changes, training on revised Procedures. Performance of effectiveness checks.

• Complete assigned CAPA Actions including creation of procedure and work instruction revisions, following company change procedure and current global regulations

• Training of staff on procedure revisions

• Implementation of procedure revisions

• Effectiveness checks of procedure changes.

• All associated documentation

• Updating of excel log tracking sheets

• Liaison/translation coordinator between sites to facilitate CAPA closures (verbal and written/ German and English)

01. 2016 – 01.2020 VARIAN MEDICAL SYSTEMS Quality Assurance

· Varian Oncology Systems Documentation QA/RA

· Process Validation & Equipment Qualification (IQ-OQ-PQ)

· Design Master Record / Design History Record compliance & maintenance

· Issue Review, CAPA & Risk Management (ISO 14971)

· Supplier Quality Management (performed 13 Supplier Audits in 2016)

· Supplier Quality Review Board, KPI management

· Medical Device Single Audit Program (MDSAP)

· ISO13485:2016 transition

10. 2014 – 12.2015 ZIMMER BIOMET Regulatory Compliance

· Regulatory Compliance & Quality, CAPA & Risk Management

· Global Change Management Process & Local QMS Documentation

· In Vitro Diagnostic Devices 98/79/EC (ANNEX III)

· CE declaration, Essential Requirements Compliance

· Packaging Sterilized Medical Devices, Process Validation

· Responsible Standards Compliance: ISO13485, 21CFR820, ISO14971

IVD-ECD 98/79/EC, MDD 93/42/EEC, ISO11607, GHTF/SG3/N99-10:2004

06. 2010 - 08.2013 SCHNEIDER Electric Quality Manager

· Quality Manager for the Swiss Business Unit

· Global Manufacturing & Supplier Approval, Assessment, Auditing, Selection & Qualification

· Global Manufacturing & Quality Assurance: Switzerland, Germany, France, Denmark, Finland, USA, India, China

· ISO certification & CE declaration, Project Risk & Life Cycle Management

· Industrialization/Manufacturing transfer to Shanghai China (JABIL)

09. 2008 - 05. 2010 ABB Switzerland AG Quality Manager-Traction

· Project/Product/Process Q-Management, Q-strategy, Q-Manual

IRIS certified auditor, ISO 9001, ISO 14001

FMEA, PDCA, DMAIC, SPC, 8D, 5S, 6σ, KPI, LEAN, OPEX

Continuous Improvement, Supplier Auditor, Cost of Poor Quality

Stakeholder management (Deutsche Bahn, Stadler Rail, internal)

11. 2007 - 08. 2008 ELECTROLUX Switzerland AG Quality & Site Management

Production of High-End Home Appliances for the SWISS market.

Quality management (7 direct reports), 450 total workforce

Leadership & Business Excellence Management, Q-Reporting

Performance Effectiveness, LEAN, FMEA, 8D, 6 sigma, PDCA cycle

Continuous improvement, Auditing, Stakeholder Management

Scrap & Rework reduction, Failure analysis, Cost of Poor Quality

06. 2005 - 10. 2007 PHILIPS Semiconductors / NXP CH Industrial Management

· Lead an international manufacturing team (7 Engineers)

Technology transfer, manufacturing ramp-up & automation

Multi-site project management: CH, France, Nederland, Taiwan

Continuous improvement: yield, testing, manufacturing flexibility

04. 2001 - 05. 2005 BOOKHAM Technology CH Yield / Manufacturing Manager

· Built and led a dynamic team of 40 manufacturing/engineering staff

Lead New Product Introduction

Identified and analyzed yield detractors

Corrective actions implementation strategy

Critical process parameters identification & monitoring

11. 2000 - 03. 2001 INFINEON Technologies DE IT Module Leader

Led a group of 10 manufacturing personnel

Optimization of complex metrology tools, identification, analysis and correlation of process and tool parameters, process changes

01. 1999 - 10. 2000 PHILIPS Electronics USA & Canada Prod. Manager / Scientist

New Product Introduction, market analysis. Sales and marketing support: prepared, organized and conducted customer training

Responsible for all scientific activities within the Design and Development

01. 1996 - 12. 1998 PROTO Manufacturing Canada Physicist

· Project & product management

R&D in the x-ray diffraction field

prototype design

01. 1990 - 12. 1995 Zurich University / ETH Zurich Researcher

IV-VI semiconductors, x-ray diffraction, IR,

Thin film vacuum deposition methods & techniques

Vaan der Graaff linear accelerator measurements

Rutherford Backscattering spectrometry on semiconductors

PhD Thesis: Strain Relaxation in Epitaxial layers

CAREER MILESTONES

BD-Wangs (SMAG): Lead Auditor ISO 13485:2016, 20 on-site supplier Audits/Reports

Laborie Med. Tec: CAPA remediation, FDA & Notified Body audit preparation

Varian Med. Sys: RA/QA, DHR, DMR maintenance, supplier audits compliance

Zimmer- Biomet: Global QMS, CAPA and compliance to all applicable standards

Schneider Electric: WISER™ System quality assurance and market launch in France

ABB Switzerland: Led the International Railway Industry Standard (IRIS) certification

ELECTROLUX AG: Site Management, high-end home appliances manufacturing plant

PHILIPS AG / NXP: NEXPERIA™ IC ramp-up and mass production transfer to TAIWAN

Bookham / Oclaro: Yield increase up to 95% of the submarine pump laser production line

PHILIPS Analytical: PHILIPS PLM-150 photoluminescence-mapper, optical design and market launch in USA & Canada

LANGUAGES

German: fluent

English: fluent

COMPUTER SKILLS

Microsoft Office suite, SAP, EtQ, ViFlow

STUDIES

2002 – 2004 MBA: University of Strathclyde, Glasgow-UK, EQUIS, AMBA, AACSB

1990 – 1994 PhD: Experimental Physics at the University of Zurich, Switzerland

1982 – 1986 MSc: Theoretical Physics at the University of Bucharest

PERSONAL

Citizenship: SWISS / Canadian / Romanian

Birth Date: 29 November 1960

STRATEGIC Detailed planning followed by disciplined execution

SELF STARTER Leader by example, actions are more effective than words

EMOTIONAL Enthusiastic, motivating, communicative, respectful, driven by passion

HANDS-ON I hear and I forget, I see and I remember, I do and I understand

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