Responsible for injection moulding suppliers. Communication with suppliers. Project lead of transfer projects. Support with MDR topics in purchasing department.
09/2019
-
02/2020
Projektleiter im Bereich Healthcare
Medela AG
(1000-5000 Mitarbeiter)
Pharma und Medizintechnik
Project lead for product supplier move. Coordinating and building up a team with 6 persons. Communication and coordination with supplier overseas. Fulfilling regulatory (MDR) and internal requirements for product documentation during move.
01/2018
-
10/2019
Lead Auditor
Stryker
(1000-5000 Mitarbeiter)
Pharma und Medizintechnik
Execution of Risk-based supplier audits according EN ISO 13485.
Identification of observations and findings and closure of relating NC records
Train and educate suppliers on regulatory requirements and Stryker expectations
04/2015
-
09/2015
Senior Supplier Quality Engineer / Lead Auditor
Zimmer Biomet GmbH
(500-1000 Mitarbeiter)
Pharma und Medizintechnik
Review and Remediation of Process Validation Documents
GMP, GDP, CE conformity
21 CFR 820, ISO 13485, Desktop Audit execution
Support in execution of validations for special processes at different suppliers. Execution of supplier audits according ISO 13485 and 21CFR820
CAPA lead training (supplier validation related)
01/2014
-
03/2015
Projektleiter, Team Leader Validation Group
Johnson & Johnson, Depuy Synthes
(5000-10.000 Mitarbeiter)
Pharma und Medizintechnik
Coordination of remediation according to 21 CFR 820 / ISO 13485
Process validation (IQ, OQ, PQ)
GMP, GDP, CE conformity
Project management and team leading (32 team members)
CAPA responsibility (project related, validation)
Reporting to upper project management
06/2013
-
12/2013
Senior Validation Engineer
Johnson & Johnson, Depuy Synthes
(5000-10.000 Mitarbeiter)
Pharma und Medizintechnik
Review according to 21 CFR 820 and ISO 13485
Process validation (IQ, OQ, PQ)
Review of test and verification activities in accordance with process validation and equipment validations
GMP, GDP, CE conformity
Reisebereitschaft
Verfügbar in den Ländern
Deutschland, Österreich und Schweiz
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