Quality Engineer

4 weeks ago


Temecula, United States GForce Life Sciences Full time

Quality Engineer – on-site in Temecula, CA

Summary

Our client, a Fortune-500 medical device company, is looking for a Quality Engineer to provide support to product development teams (Design Controls) in their Vascular unit on-site in Temecula, CA.


Term & Start

  • 11-month contract, starting 4/29/24
  • On-site in Temecula, CA (92591)
  • Pay Rate: $35-40/hr ($70-80k annually)
  • FT hours, M-F 8a-5p
  • Business Unit: Vascular

Main Duties

· Authors and reviews/approves protocols and report to support Design Controls deliverables

· Performs data analysis to support product development studies

· May be responsible for creating risk assessment documentation

· May be responsible for test method validation

· Develops/implements process monitoring requirements and documentation

· Identifies and controls Manufacturing process defects by participating in efforts/teams focused on identifying the primary root causes and implementing corrective and preventative actions

· Creates product specifications, quality specifications and quality plans in conjunction with other product development team members

· Plans, organizes, and prioritizes own daily work routine to meet established schedule


Mandatory Requirements to Succeed in Role

· BS in Engineering

· Medical device regulation/guidance (FDA, ISO)

· Experience with the following:

o Risk management

o Test method validation

o Design Verification (Filing and Aging studies)

o Process validation

o Data analysis (JMP)

o Statistical equivalence studies


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