
Paula Esty
Paula has extensive quality and regulatory leadership experience, including development and implementation of national and global Q&R compliance... | 31 Roger Belanger Drive, Bellingham, United States
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Paula Esty’s Emails pa****@ph****.com
Paula Esty’s Phone Numbers 1800257****
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Paula Esty’s Location 31 Roger Belanger Drive, Bellingham, United States
Paula Esty’s Expertise Paula has extensive quality and regulatory leadership experience, including development and implementation of national and global Q&R compliance programs, systems, and operations. Paula brings a hands-on approach with a proven track record of building infrastructure and teams that drive customer satisfaction, operational performance for process transparency, supplier performance, regulatory compliance, sustainability, solution safety, patient experience, product stewardship, risk management, and continual improvement. Her experiences include a working knowledge of global cross process markets including hospitals, medical devices, medical software solutions, pharmaceuticals, life science, energy, commodities, high tech electronics, and end of life management. Examples of hands-on health-tech experience includes: Implantable, wearable, and monitoring devices; Medical testing scan, x-ray, and in-vitro, devices; Cloud based medical big data analytics and solutions; Hospitals and Health systems; Large scale sterilizations; Pharmaceutical and medical device manufacturing in house and global contract manufacturing, etc... Accomplishments include: Numerous successful implementation of systems and processes (IS0 9001, ISO 13485, cGMP, GCP, GLP, GVP, CLIA, JC, FDA, IEC 60601, IEC 62304, CMDR, MDD, JPMDA, HIPAA, NIST, CE, ISO 27001, ISO 14001, OHSAS 18001, Global electrical and electronic product compliance WEEE, RoHS, etc.) Executive management strategy development, deployment - bringing the vision to life; Driving process metrics for improved performance; Providing value added process, methods, and systems to multiple organizations. Board Membership • 2009 to Present Director - National Quality Assurance, USA: Independent Certification Board • 2014 to Present Director – American Society of Quality, Currently Director Biomedical Division • 2015 to Present Director - Special Education Professional Advisory Council
Paula Esty’s Current Industry Philips
Paula
Esty’s Prior Industry
Analog Devices
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Capaccio Environmental Engineering
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Schnitzer Steel
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Philips
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Work Experience

Philips
Head Of Quality And Regulatory
Sun Jun 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time) — Present
Schnitzer Steel
Senior Manager, National Quality And Export Licensing
Fri Apr 01 2011 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu May 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time)
Capaccio Environmental Engineering
Senior Systems Specialist
Mon Nov 01 2004 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Apr 01 2011 00:00:00 GMT+0000 (Coordinated Universal Time)
Analog Devices
World Wide Quality
Mon Jan 01 1996 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Nov 01 2004 00:00:00 GMT+0000 (Coordinated Universal Time)