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Quality Assurance & Regulatory Compliance Medical Devices

zuletzt online vor 7 Tagen
  • 105‐125€/Stunde
  • 8820 Wädenswil
  • Europa
  • en
  • 22.03.2024

Kurzvorstellung

21 CFR 820, EU MDR 2017/75, MDSAP, cGMP
Certified 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
Risk Managemet FMEA

Qualifikationen

  • Auditor
  • CE-Kennzeichnung
  • Certified Lead Auditor ISO 13485
  • DIN EN ISO 13485
  • DIN EN ISO 9001
  • Fehlermöglichkeits- und Einfluss-Analyse (FMEA / FMECA)
  • Gute Herstellungspraxis (GMP)
  • Prozessvalidierung
  • Six sigma
  • Vorbereitung auf QM-Zertifizierung (ISO)

Projekt‐ & Berufserfahrung

Contractor Quality Assurance
Roche Pharma Basel, Basel
9/2023 – 11/2023 (3 Monate)
Life Sciences
Tätigkeitszeitraum

9/2023 – 11/2023

Tätigkeitsbeschreibung

• Risk Assessment of Risk Events
• Design & Process FMEA
• Risk Event Verification
• Risk Event Transfer (Stature DB to Veeva Vault)

Eingesetzte Qualifikationen

Fehlermöglichkeits- und Einfluss-Analyse (FMEA / FMECA), Risikomanagement

Contractor Quality
Abiomed Europe GmbH, München
6/2023 – 9/2023 (4 Monate)
Life Sciences
Tätigkeitszeitraum

6/2023 – 9/2023

Tätigkeitsbeschreibung

CAPA remediation project
• Retrospective review of Quality Notification documentation 2021-2023
• Retrospective review of CAPA documentation 2021-2023
• SCARs follow-up and closure
• Equipment Calibration nonconformities

Eingesetzte Qualifikationen

Qualitätsmanagement / QS / QA (IT)

Contractor Supplier Quality
BDPI-Wangs (Straub Medical AG), Wangs
9/2020 – 9/2022 (2 Jahre, 1 Monat)
Life Sciences
Tätigkeitszeitraum

9/2020 – 9/2022

Tätigkeitsbeschreibung

Supplier Gap Analysis - Review of existing supplier files and Supplier Quality
procedures to assess adherence with corporate and MDR requirements
• Drive gap analysis & perform various remediation activities
• QMS harmonization: BD USA - Straub Medical Switzerland
• Transfer of Supplier Files into a standardized BD electronic repository
• Maintenance of the Straub Medical Approved Supplier List (ASL)
• Lead Supplier Auditor (conducted 20 supplier audits in 2021-2022)
• SCAR & CAPA process owner
• Conducting supplier re-approval activities in accordance with governing
procedures

Eingesetzte Qualifikationen

Auditor, DIN EN ISO 13485

Contractor Quality Assurance
LABORIE MEDICAL TECHNOLOGIES, Attikon
2/2020 – 8/2020 (7 Monate)
Life Sciences
Tätigkeitszeitraum

2/2020 – 8/2020

Tätigkeitsbeschreibung

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
• QMS harmonization: Canada-USA-Switzerland
• Training of staff on QMS activities: usage, update, changes, maintenance
• 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

Eingesetzte Qualifikationen

DIN EN ISO 13485

Sr. QA Specialist
Varian Medical Systems, Dättwil Baden
1/2016 – 1/2020 (4 Jahre, 1 Monat)
Life Sciences
Tätigkeitszeitraum

1/2016 – 1/2020

Tätigkeitsbeschreibung

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 50 Supplier Audits in the last 4 years)
Supplier Quality Review Board, KPI management
Medical Device Single Audit Program (MDSAP)
ISO13485:2016 transition

Eingesetzte Qualifikationen

DIN EN ISO 13485

quality & regulatory compliance
Zimmer Biomet, Winterthur
10/2014 – 12/2015 (1 Jahr, 3 Monate)
Life Sciences
Tätigkeitszeitraum

10/2014 – 12/2015

Tätigkeitsbeschreibung

• Quality & Regulatory Compliance, CAPA & Risk Management
• Global & Local Quality Management System Documentation
• In Vitro Diagnostic Devices, Packaging Sterilized Medical Devices
• Responsible Standards Compliance: ISO13485, 21CFR820, ISO14971
IVD-ECD 98/79/EC, MDD 93/42/EEC, ISO11607

Eingesetzte Qualifikationen

Fehlermöglichkeits- und Einfluss-Analyse (FMEA / FMECA)

Quality Manager (Festanstellung)
Schneider Electric, Zürich
6/2010 – 8/2013 (3 Jahre, 3 Monate)
High-Tech- und Elektroindustrie
Tätigkeitszeitraum

6/2010 – 8/2013

Tätigkeitsbeschreibung

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)

Eingesetzte Qualifikationen

FMEA (Failure Mode and Effects Analysis), Auditor, DIN EN ISO 9001

Quality Manager (Festanstellung)
ABB Switzerland, Turgi AG
8/2008 – 10/2010 (2 Jahre, 3 Monate)
Maschinen-, Geräte- und Komponentenbau
Tätigkeitszeitraum

8/2008 – 10/2010

Tätigkeitsbeschreibung

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)

Eingesetzte Qualifikationen

Six sigma

Quality Manager GL Mitglied (Festanstellung)
Electrolux Switzerland, GL Switzerland
11/2007 – 8/2008 (10 Monate)
Fertigungsindustrie
Tätigkeitszeitraum

11/2007 – 8/2008

Tätigkeitsbeschreibung

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

Eingesetzte Qualifikationen

Lean Management

Industrial Engineer (Festanstellung)
Philips Semiconductors - NXP, Zürich
6/2005 – 10/2007 (2 Jahre, 5 Monate)
High-Tech- und Elektroindustrie
Tätigkeitszeitraum

6/2005 – 10/2007

Tätigkeitsbeschreibung

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

Eingesetzte Qualifikationen

Technologieplanung

Zertifikate

Post-Marker Surveillance and Vigilance
2019
Medical Devices Quality Manager Certificate
2018
ISO 13485:2016 Transition & Auditor
2017
MDSAP Fundamentals & Requirements
2017

Ausbildung

MBA
Busieness Administration
2004
UK
Physik
PhD Uni Zurich
1994
Zurich

Über mich

• 21 CFR 820, EU 2017/745, ISO 13485:2016, 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/harmonization
• 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)
• Technical Files compliance/analysis (CE submission)
• Device Master Record & Device History Record review & maintenance

Weitere Kenntnisse

• 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

Persönliche Daten

Sprache
  • Englisch (Muttersprache)
Reisebereitschaft
Europa
Arbeitserlaubnis
  • Europäische Union
  • Schweiz
  • Vereinigte Staaten von Amerika
Home-Office
bevorzugt
Profilaufrufe
2595
Alter
63
Berufserfahrung
29 Jahre und 2 Monate (seit 01/1995)
Projektleitung
10 Jahre

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