Carmen Alt
Quality Systems Engineer at Tem Innovations GmbH- Claim this Profile
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Bio
Experience
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Tem Innovations GmbH
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Germany
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Medical Device
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1 - 100 Employee
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Quality Systems Engineer
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Oct 2021 - Present
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Head of Customer Support, Safety and Surveillance
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Jan 2006 - Present
- Head of the Customer Support Team with employee responsibility- PMS according to IVDR- PMS Plan, PMS Report and PSUR- Complaint processing for Invitro-Diagnostic products- used to work in a regulated environment according to EN ISO 13485- Process owner for customer feedback and complaint management- CAPA process- Implementation of Advisory Notices and FSNs- Customer Support worldwide for a supplier of invitro diagnostics- Important role in a cross-functional team of R&D, Production, Marketing and Sales- Responsible for customer training and advising- Represantative at local and international meetings- Specialist for HPLC and LC-MS/MS
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Sales Representative
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Oct 1999 - Dec 2005
Sales Representative for in-vitro diagnostica in the DACH regionApplication Specialist for HPLCAdvising and training of customersOn-site support for HPLC and complete kits for HPLCInstallation of HPLC complete kits
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Education
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Ludwig-Maximilians Universität München
PhD, Pharmacology and Toxicology -
Technische Universität München
Diplom, Chemie -
Imperial College London
Chemistry