Erika Gremlich
Fähigkeiten und Kenntnisse
Werdegang
Berufserfahrung von Erika Gremlich
- Current 5 years and 5 months, since Jan 2021
Senior Quality Management System and Compliance Manager
Straub Medical AG
• Responsible to maintain compliance to QMS requirements as defined by the applicable norms and regulations (ISO13485, MDR, FDA, QSR, ASTM and other international standards) • Leading QMS Integration and Harmonization Project • Leading Supplier Quality department • Managing Quality Personnel responsible for NC and CAPA • Acting as Site Audit Program Manager, execution of internal Audits and SME for external Audits • Reporting on QMS related metrics • Leading CRB, Monthly Quality Meeting and support MR
- 2 years and 6 months, Jul 2018 - Dec 2020
Senior Consultant
Sthree Switzerland GmbH
Medical Devices: - Quality Record Remediation (Work Orders, Incoming Inspection, CAPAs, NCs and Change Requests) - Provision of various trainings for Quality Records - Execution of Internal Audits - Member of the Review Board for new Change Requests, NCs and CAPAs - Support of daily business activities related to QM and QA
- 1 year and 6 months, Jun 2019 - Nov 2020
Quality Management and Regulatory Affairs Manager
REGEDENT AG
- Supporting coordination and monitoring of activities related to certification of QMS - Supporting creation, change, training, distribution and archiving of QMS documents - Supporting planning and preparation of internal and external audits - Initiating and monitoring of NCs and CAPAs to address quality non-conformities - Supporting regulatory activities - Supporting periodical data analysis and evaluation performed to assess the QMS
- 3 years and 4 months, Oct 2016 - Jan 2020
Senior Consultant
Consultys Schwitzerland AG (former Prismond Group AG until Q1/2019)
Senior Consultant Medical Devices for various projects
- 10 months, Jan 2019 - Oct 2019
Quality Engineer Consultant
DePuy Synthes GmbH (companies of J&J) / Switzerland
External Consultant for MDR Implementation: Supply Chain, Direct Marking and Process Documentation/Approval
- 2 years, Aug 2016 - Jul 2018
Deputy Head CTU Hirslanden / Head QA
Clinic Hirslanden Zürich
- 2 years and 9 months, Sep 2013 - May 2016
Senior Consultant
DePuy Synthes GmbH (companies of J&J) / Switzerland
- 13 years and 3 months, Jun 2002 - Aug 2015
Scientific Assistent
USZ Zürich
- 3 years and 4 months, Jul 2011 - Oct 2014
Chief Operating Officer
Advanced Urology Solutions
- 1 year and 6 months, Mar 2012 - Aug 2013
Chief Quality Assurance
NeMo Devices AG
- 1 year, Mar 2011 - Feb 2012
Business Development
Kinder Permanance
- 7 years and 10 months, May 2003 - Feb 2011
Swiss Office Leader
Timaq Medical Imaging
- 6 years, Jun 2004 - May 2010
Head of Project Management
Swiss Association of Pharmaceutical Professionals
Project Leader of the SwAPP Group "How2GCP.ch"
- 8 years and 2 months, Jul 1998 - Aug 2006
Deputy CEO
DC Dental
- 2 years and 10 months, Jun 2002 - Mar 2005
CRA
USZ Zürich
- 2 years and 6 months, Sep 2001 - Feb 2004
Chief Scientific Officer and Member of the Board
Pharma Nation Network / ETH Zurich
- 7 years and 5 months, Apr 1994 - Aug 2001
QA Manager
PFC Pharma Focus Consulting
Ausbildung von Erika Gremlich
- 1 month, Jul 2022 - Jul 2022
Lead Auditor
Zertified by SAQ Qualicon
- 2 months, Mar 2018 - Apr 2018
Education
SAQ Qualicon
ISO 19011 and ISO 13485
SwAPP - Diploma with ongoing CME
MSc, Dipl. Pharma
Eidgenössische Technische Hochschule Zürich ETHZ
Sprachen
German
C2 (Verhandlungssicher / Muttersprachlich)
English
C1 (Fließend)
French
C1 (Fließend)
Italian
A1-A2 (Grundkenntnisse)
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