freiberufler Senior Consultant QA & RA auf freelance.de

Senior Consultant QA & RA

offline
  • auf Anfrage
  • 19053 Schwerin
  • National
  • de  |  en
  • 01.01.2021

Kurzvorstellung


Qualifikationen

  • FMEA (Failure Mode and Effects Analysis)
  • FMECA (Failure Mode and Effects and Criticality Analysis)
  • Management (allg.)
  • Recht (allg.)
  • Schulung / Coaching (allg.)

Projekt‐ & Berufserfahrung

Senior Consultant Quality Assurance / Regulatory Affairs
EMERGO ca. 50 verschiedene Kunden, deutschlandweit und andere Länder
9/2012 – 1/2016 (3 Jahre, 5 Monate)
Life Sciences
Tätigkeitszeitraum

9/2012 – 1/2016

Tätigkeitsbeschreibung

MAIN PROJECTS WITHIN THE LAST 15 MONTH - SELECTION

Fourth quarter 2015

o Form 483 Response of FDA inspection observations, lead project consultant for 21CRF820 and QS remediation program, Manufacturer of dental equipment (Greece)
o Response of FDA inspection observation recorded on form 483 - lead project consultant for 21CRF820 program, Manufacturer of Medical Device Software (Netherlands)
o QSR 21CFR 820 GAP analysis, lead auditor and project consultant for 510(k) submission, Manufacturer of therapeutic devices (Hessen)
o FDA PMA supplement support for an active device class III, lead consultant, Manufacturer of active medical devices (Baden-Würtenberg)
o Health Canada CMDCAS support for Medical Device Establishment Licence and Medical Device Listing as project consultant, Manufacturer of nonactive eye products (Bavaria)

Third quarter 2015

o Preparation of the company regarding upcoming FDA inspection including FDA mock audit and revision of procedures regarding 21 CFR 820 requirements, lead auditor and trainer, Manufacturer of urology devices (Netherlands)
o Supplier audit regarding 21 CFR 820 requirements, lead auditor, Manufacturer of medical imaging software (US and Germany)
o CE Marking consulting including classification questions and Technical File support, Manufacturer of Therapeutic Devices (Austria)

Second quarter 2015

o Preparation and response to FDA warning letter including strategy consulting, quality system remediation, CAPA support and effectiveness check audit and report; successful – closed out, Manufacturer of active device class III (Baden-Würtenberg)
o 510(k) submission project support Manufacturer of ultrasonic surgery equipment and instruments (Schleswig-Holstein)
o CE Marking support for the German facility including strategy consulting and on-site training for Medical Device Advisers and Safety officer according to German Medical Device Law, Manufacturer of non-active medical devices (Nordrhein-Westfalen)

First quarter 2015

o Preparation and response to FDA warning letter including strategy consulting, quality system remediation, CAPA and complaint support and effectiveness check audit and report; successful – closed out, Manufacturer of disposables (Brandenburg)
o CE Marking and technical documentation support including Gap analysis and DIMDI support, lead consultant, Manufacturer of non-active medical devices (Mecklenburg-Vorpommern)
o Regulatory Affairs support for EU countries as project consultant, Manufacturer of non-active products (Bavaria)

Fourth quarter 2014

o Preparation of FDA inspection including GAP analysis and strategy consulting, lead consultant, Manufacturer of medical device software (Brandenburg)
o Assessment of audit performance of auditors at supplier audits of critical components, lead auditor, Manufacturer of medical imaging software (Switzerland)
o Regulatory assessment of borderline products including strategy consulting for China, Korea, Malaysia, New Zealand, lead consultant, Manufacturer of non-active medical products (Nordrhein-Westfalen)

Eingesetzte Qualifikationen

FMEA (Failure Mode and Effects Analysis), Requirement Analyse, Medizinische Messtechnik, Technisches Qualitätsmanagement / QS / QA, Medizintechnik / Labortechnik

Ausbildung

Maschinenbau / Biomedizinische Technik
Dipl.-Ing.
1996
Rostock

Weitere Kenntnisse

o Implementation and maintenance of quality management systems for compliance with 21 CFR Part 820 quality system regulation, ISO 13485:2003, and ISO 9001:2008
o US FDA 510(k) submission support
o Regulatory strategies for new product development
o Conformity assessments for CE Marking to 93/42/EEC, Medical Devices Directive; 98/79/EC, In Vitro Diagnostic Medical Devices Directive; and 90/385/EEC, Active Implantable Medical Devices Directive
o Conformity assessments for Canadian Medical Devices Conformity Assessment System (CMDCAS) to CAN/CSA ISO 13485:2003 for quality management systems
o Internal quality system and supplier quality audits for medical devices and in vitro diagnostics
o Validation support for various processes; sterilization, cleaning, software, equipment
o CE Marking Support for Technical Files and Design Dossiers
o Development of EN ISO 14971 Risk Management Files
o Clinical Evaluations Support according MEDDEV 2.7.1

Persönliche Daten

Sprache
  • Englisch (Fließend)
  • Deutsch (Muttersprache)
Reisebereitschaft
National
Arbeitserlaubnis
  • Europäische Union
Profilaufrufe
1685
Alter
56
Berufserfahrung
24 Jahre und 2 Monate (seit 01/2000)
Projektleitung
15 Jahre

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