Quality Engineer
4 weeks ago
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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