Experience

Oriel STAT A MATRIX

• United States
• Business Consulting and Services
• 1 - 100 Employee

• Independent Senior Consultant

  • May 2014 - Present

  Oriel STAT A MATRIX helps medical device, pharmaceutical, and biotechnology manufacturers achieve compliance with global regulations while improving business processes, thus reducing both cost and risk. Our consultant team – life sciences industry experts and former FDA professionals – will ensure that your RA and QA systems are optimized for compliance and effectiveness. We can also help organizations develop in-house expertise with our full range of life sciences RA/QA training courses. Oriel STAT A MATRIX helps medical device, pharmaceutical, and biotechnology manufacturers achieve compliance with global regulations while improving business processes, thus reducing both cost and risk. Our consultant team – life sciences industry experts and former FDA professionals – will ensure that your RA and QA systems are optimized for compliance and effectiveness. We can also help organizations develop in-house expertise with our full range of life sciences RA/QA training courses.



M.J.Zeitner & Associates

• Port Ludlow, Washington

• CEO & President

  • Jan 2014 - Present

  Independent consultant with 30+ years expertise in Medical Device Quality Assurance, ISO 9000 and related standards, audit service and support. Independent consultant with 30+ years expertise in Medical Device Quality Assurance, ISO 9000 and related standards, audit service and support.



Philips Healthcare

• 22100 Bothell Everett Highway Bothell, WA 98021-8431 (425) 487-7000

• Quality & Regulatory Engineer

  • Jan 2012 - Jan 2014

  Provide a range of quality and regulatory affairs experience at Philips, a premier ultrasound research,development and manufacturing facility. Provide a range of quality and regulatory affairs experience at Philips, a premier ultrasound research,development and manufacturing facility.



Philips Ultrasound

• Bothell, WA

• Senior QE

  • Mar 2005 - Apr 2008

  Global medical device manufacturer of both the iE33 electrocardiography intelligent echo and the iU22 multidimensional ultrasound and diagnostic monitoring Systems. As Senior Quality Assurance Engineer, had key responsibility for quality engineering in both sustaining existing products, New Product Development; and enjoyed various oversight and functional responsibilities including:New Product Development, Audit, Documentation, and Medical Product Outsourcing. Global medical device manufacturer of both the iE33 electrocardiography intelligent echo and the iU22 multidimensional ultrasound and diagnostic monitoring Systems. As Senior Quality Assurance Engineer, had key responsibility for quality engineering in both sustaining existing products, New Product Development; and enjoyed various oversight and functional responsibilities including:New Product Development, Audit, Documentation, and Medical Product Outsourcing.



TriPath Imaging

• Medical Equipment Manufacturing
• 1 - 100 Employee

• Quality Manager

  • Sep 2000 - Aug 2003

  Quality Assurance Management responsibility for the manufacturing and development of FocalPoint™ medical imaging and visual intelligence technologies for detection of cervical cancer. Routine day-to-day responsibilities included oversight and training of all quality engineering, supplier assessment, compliance administration, document control, and receiving inspection personnel. Quality Assurance Management responsibility for the manufacturing and development of FocalPoint™ medical imaging and visual intelligence technologies for detection of cervical cancer. Routine day-to-day responsibilities included oversight and training of all quality engineering, supplier assessment, compliance administration, document control, and receiving inspection personnel.



Medtronic Physio-Control

• Redmond, WA

• Senior Quality Engineer

  • May 1982 - Feb 1996

  Internationally recognized manufacturer of LifePak® Cardiovascular Defibrillation and Monitoring Systems, Disposables, and associated medical support equipment. As Senior Quality Assurance Engineer, had key responsibility for quality engineering in both sustaining existing products, and in New Product Development and validation process; enjoyed various oversight and functional responsibilities including:New Prduct Development, procurement, and testing. Internationally recognized manufacturer of LifePak® Cardiovascular Defibrillation and Monitoring Systems, Disposables, and associated medical support equipment. As Senior Quality Assurance Engineer, had key responsibility for quality engineering in both sustaining existing products, and in New Product Development and validation process; enjoyed various oversight and functional responsibilities including:New Prduct Development, procurement, and testing.