Job Description
Job Title: Quality Engineer III
Job Description
We are seeking a highly experienced Quality Engineer to lead post-acquisition quality remediation efforts at our Irvine, CA site. This onsite role will focus on the remediation, standardization, and sustainment of Process Failure Mode and Effects Analyses (PFMEAs) and Test Method Validation (TMV) documentation to ensure compliance with internal quality standards and applicable regulatory requirements. This role is ideal for a seasoned medical device quality professional with strong expertise in risk management, test method validation, and measurement system analysis, capable of independently assessing legacy documentation, developing remediation strategies, and collaborating cross-functionally to integrate acquired products and processes into an established Quality Management System (QMS).
Responsibilities
+ Lead and execute PFMEA remediation activities, including gap assessments, risk re-evaluations, updates, and alignm...
Job Description
We are seeking a highly experienced Quality Engineer to lead post-acquisition quality remediation efforts at our Irvine, CA site. This onsite role will focus on the remediation, standardization, and sustainment of Process Failure Mode and Effects Analyses (PFMEAs) and Test Method Validation (TMV) documentation to ensure compliance with internal quality standards and applicable regulatory requirements. This role is ideal for a seasoned medical device quality professional with strong expertise in risk management, test method validation, and measurement system analysis, capable of independently assessing legacy documentation, developing remediation strategies, and collaborating cross-functionally to integrate acquired products and processes into an established Quality Management System (QMS).
Responsibilities
+ Lead and execute PFMEA remediation activities, including gap assessments, risk re-evaluations, updates, and alignm...
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