Process Engineer Consultant II at Fremont CA

Applicants must be eligible to work in the specified location


This is Rohini with SSI, We have an immediate opening for Process Engineer Consultant II with our Direct client. If you are interested please reach me with your Updated Resume

Title: Process Engineer Consultant II

Duration: 6months + (will extend after that)

Location: Fremont CA 94555


  • “Experience: Minimum 12 years professional experience in the applicable role. E Education: Bachelor’s/Master’s degree in Engineering. Experience with drug-device combination devices preferred. Expert and technical lead with proven experience. Guide and participate in test method validation, risk assessment, requirement development, protocol and validation report writing.
  • Maintain, Validate and Release Test Systems in Production Environment, ideally in FDA regulated business. Firm understanding of IQ, OQ, PQ and Software Validation requirements and practices. Expertise in PFMEA, Gage R&R, test system and manufacturing software validation for medical devices within manufacturing environment.
  • Ability to learn and adapt to Philips QMS and work closely with Philips Engineering community on new validation methods and re-validation projects. Guide and participate in bug testing, identification, and problem solving, oversees the validation process, the QMS system and participates in the Internal Quality Audits. Write and maintain FDA level validation protocols and reports. Support quality planning activities on new and existing programs.
  • Investigate customer quality issues and requests. Interpret and implement ISO9000/13485 and FDA standards. Support internal audits. May require focus on CAPA execution in Operations.”

Fremont California, United States of America

Rohini KorrapatiĀ 


12/21/2018 8:03:22 AM

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