Carsten Jähnisch

Experience

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  PerkinElmer Optoelectronics

  May 2002 - Jul 2009

  o Quality liaison and support of key customers o Return material goods handling o Coordination of quality measures with the Sites in Asia o Quality planning: Responsible collaboration in customer projects (Automotive, Medical Device and safety related devices)o Collaboration in Quality Management Projects o Responsible for RoHS and WEEE conformity o Responsible for planning, processing and documentation of qualification tests o Internal audits Results:o Successful integration of a product line into the existing ISO 9001 Management System o Organization of a internal test lab o Responsible collaboration in successful certification project for ISO TS 16949 o Integration of RoHS requirements into the Quality Management Systemo Successful application of an exemption to the RoHS Show less

  • Engineer Quality assurance and quality planning for Commercial Sensors

    Mar 2004 - Jul 2009

  • Production Engineer Thermopile Sensor Moduls

    May 2002 - Mar 2004
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  PerkinElmer Technologies

  Aug 2009 - Aug 2013

  o Quality liaison and support of key customers o Coordination of SQA: SCAR and Supplier auditso Corrective Actions / Preventive Actions (CAPA)o Coordinator internal Audits, internal Auditor o Management reviews: Planning, realization and documentation o Reportingo Collaboration in R&D projects and product introductions according to NPI processo Project lead for CI Projects Results:o Certification and recertification of the site according to ISO 13485:2012o Certification of the site according to OHSAS18001 o Intensification of the partnership QA/QM with Production and R&D Show less o Preservation and development of the QM System o Coordinator internal audits, internal auditor o Management reviews: Planning, realization and documentationo Reportingo Quality liaison and support of key customers o Coordination of SQA: SCAR and Supplier audits o Quality assurance production o Responsible collaboration in R&D projects and product introductions according to NPI process o Coordination of measuring and test equipment management, management of 1 direct report o Coordination Doc Services, management of 1 direct report Results:o Certification and recertification of the site according to ISO9001 and OHSAS18001o Successful „Start of Production“ of 2 product lines according to NPI processo Installing QM/QA as partner of production and R&D Show less

  • QA Manager

    Dec 2010 - Aug 2013

  • QMR ISO 9001; EH&S-MR OHSAS 18001

    Aug 2009 - Dec 2010
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  Sanofi-Aventis Deutschland GmbH

  Sept 2013 - now

  o Quality and Regulatory liaison for Design and Development projects o Collaboration in Quality Systems Team o Internal Auditor / Supplier Auditor o Collaboration in External Audits/Inspections Team o Purchasing Controls / Supplier Management within the project team Results:o Supplier evaluation and approval of key supplier o Creation of Template Quality Assurance Agreement o Creation and implementation of new Purchasing Controls SOPo Definition and description of QA/RA approach to handling of Device Master Files o Ensuring PAI readiness in regards to Purchasing Controls Show less

  • Quality assurance Manager

    May 2015 - now

  • Quality Project Manager

    Sept 2013 - May 2015