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Supplier Quality Engineer and Quality Manager responsible for managing 25 quality employees in two facilities. As ISO management representative, certified Liverpool facility in December 2015 for 9001:2008 and 14001:2004. Implemented QMS for start up company formed in 2013, including new business acquisitions.
Monitored and reported trends in supplier, manufacturing, and customer non-conformances to responsible departments. Managed supply chain performance metrics and monitoring. Met with OEM suppliers either on-site or through webinars to assess quality, delivery, SCARs, or new product development. ESD Coordinator for entire facility, and Calibration manager for 4 years.
Processed
vectored biotechnology culture from cryogenics to protein harvest to be used as
an injectable drug. Consistently
followed strict FDA standards and protocols.
Interfaced with customers and suppliers concerning quality issues, production delays, or product improvements. Supervised 15 employees on shift and made production decisions based on COPQ (cost of poor quality), production timelines, and equipment shutdown costs.
ASQ Certified Quality Engineer
ASQ Certified LSSGB
BSI Certified Lead Auditor 9001:2015
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