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Quality Engineer
Ref No.: 18-40076
Location: Santa Ana, California
Position Type:Full Time/Contract
Experience Level: 8 Years
Start Date: 06/11/2018
Technical/Functional Skills
  • Must have working knowledge of design FMEAs.
  • Must have the ability to review and revise product requirements.
  • Knowledge of the components of a Design History File (DHF) is required.
Experience Required A minimum of 3 years in the Medical Device industry.
Roles & Responsibilities
  • Perform updates to the risk management files.
  • Review Complaints data to determine the failure occurrence rates.
  • Support the remediation of DHF files, including but to not limited Requirement document updates.
  • Review traceability matrices for accuracy.
  • Support the creation and review of Change Orders.
  • Lead the closure of Non-conformances/ CAPAs.
Generic Managerial Skills       1.  Must have the ability to review and revise product requirements
Education Bachelor's degree in any discipline is required. An Engineering degree is preferred