Global Senior Quality Engineering Manager
Zimmer
Jan 2007 - Jan 2008 (1 year 1 month)
Directly reported to a global director of engineering. Managed software, hardware, system development and validation processes. Authored and executed Master Software validation, SOP, and quality plan. Developed and maintained Clinical Device software running in Zimmer’s Computer Assisted Solutions.
Key contributions:
• Managed software development and quality in all Zimmer CAS locations in the world (Montreal Canada, Winterthur Switzerland, Warsaw Indiana),
• Built the high performing team
• Led and completed FDA audit in Software segment (passed on Feb, 2008)
• Authored Master Software Validation Plan
• Authored Zimmer SOP in OTS/SOUP Software Quality
• Authored Zimmer/OrthoSoft software IQ, OQ, and PQ
• Provided expertise to Zimmer prod