Quality Engineer - Test Method Validation (TMV) Remediation
Manufacturing
Job Description
We’re looking for a senior-level Quality Engineer to support post-acquisition remediation efforts, with a strong focus on PFMEA and Test Method Validation (TMV). This individual will play a key role in evaluating legacy documentation, identifying gaps, and driving remediation to align with regulatory and internal quality standards.
\n
\n
\n Key Focus Areas
\n
- \n
- :PFMEA remediation and risk assessment update
- sTest Method Validation (TMV) development and remediatio
- nGage R&R and measurement system analysi
- sStatistical evaluation of test method
- sCross-functional collaboration with R&D, Manufacturing, and Quality team
- sIntegration of acquired processes into an established QM
\n
\n
\n
\n
\n
\n
\n
\n
S
\n Must-Have Qualification
\n
- \n
- s:5+ years of Quality Engineering experience in the medical device spa
- ceStrong hands-on experience with TMV and PFM
- EAExperience with Gage R&R / measurement system analys
- isSolid understanding of ISO 13485, ISO 14971, and FDA QSR (21 CFR 82
- 0)Experience supporting remediation or post-acquisition effor
- tsAbility to work onsite in Irvine,
\n
\n
\n
\n
\n
\n
\n
CA