Sr. Validation Engineer - Medical Devices

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Irvine, CA
$1 - $2
Job Type
Direct Hire
Bachelor of Science
Jul 24, 2018
Job ID
Validation Engineer - Medical Devices

Global medical devices leader seeks a Validation Engineer to lead validation and quality activities at the company's flagship Southern California manufacturing site.  Contract validation specialists with short work assignments will not be considered.  The Validation Engineer will:
  • Lead engineering team in new equipment qualification and validation IQ OQ PQ
  • Support QA and QC activities. 
  • Resolve technical or operational problems.  
  • Supports the development of first article inspection (FAI) program.
  • Mentor and develop less experienced quality team members
  • Leads cross function teams to support design transfer activities.
  • Performs training  policy and accepted standards.
  • Facilitates risk management in compliance to appropriate external standards and corporate policies.
  • Has advanced knowledge in the areas of installation qualification, operational qualification, performance qualification,  - IQ - OQ - PQ, process validation, design controls, risk management and statistical techniques.   
  • Responsible for ensuring compliance with all federal, state, local and company regulations, policies and procedures.
  • Performs other duties as assigned
Required Education and Skills:
  • Bachelor’s degree in engineering;  applicable disciplines could include mechanical engineering, chemical engineering, electrical engineering, manufacturing engineering, industrial engineering.  
  • 5+ years experience in medical devices, or a combination of medical device and other related industry.  Advanced degree could reduce number of years experience. 
  • Experience with non-conformance investigations, equipment qualifications, process validations, and test method validations.  IQ OQ PQ
  • Knowledge of GD&T including ability to read and interpret complex mechanical drawings.
  • Strong organizational and analytical skills. 
  • Excellent communications skills, oral, written and electronic.
  • Ability to handle multiple competing projects and priorities and effectively manage project timelines.
  • Ability to travel up to 10% of the time.