Quality Assurance & Regulatory Compliance Medical Devices
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- 105‐125€/Stunde
- 8820 Wädenswil
- Europa
- en
- 05.09.2024
Kurzvorstellung
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
Projekt‐ & Berufserfahrung
9/2023 – 11/2023
Tätigkeitsbeschreibung
• Risk Assessment of Risk Events
• Design & Process FMEA
• Risk Event Verification
• Risk Event Transfer (Stature DB to Veeva Vault)
Fehlermöglichkeits- und Einfluss-Analyse (FMEA / FMECA), Risikomanagement
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
Qualitätsmanagement / QS / QA (IT)
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
Auditor, DIN EN ISO 13485
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
DIN EN ISO 13485
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
DIN EN ISO 13485
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
Fehlermöglichkeits- und Einfluss-Analyse (FMEA / FMECA)
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)
FMEA (Failure Mode and Effects Analysis), Auditor, DIN EN ISO 9001
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)
Six sigma
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
Lean Prozesse
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
Technologieplanung
Zertifikate
Ausbildung
UK
Zurich
Über mich
• 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
• 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
- Englisch (Muttersprache)
- Europäische Union
- Schweiz
- Vereinigte Staaten von Amerika
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