Job Description
Quality Engineer - TMV (Medical Device)Overview
Seeking a Quality Engineer to lead PFMEA and Test Method Validation (TMV) remediation efforts in a post-acquisition environment. This role focuses on strengthening compliance, risk management, and quality systems.
Key Responsibilities
+ Lead PFMEA remediation and risk assessments
+ Develop and execute Test Method Validations (TMV)
+ Conduct Gage R&R (GR&R) and measurement system analysis
+ Ensure compliance with ISO 13485, ISO 14971, and FDA QSR
+ Partner cross-functionally with Engineering, Quality, and Operations
+ Support audits and QMS integration efforts
Qualifications
+ Bachelor’s in Engineering
+ 5+ years in medical device quality engineering
+ Strong experience with PFMEA, TMV, and statistical analysis
+ Design Quality experience
+ Knowledge of FDA/ISO standards
#ACTservices26Job Type & Location
This is a C...
Seeking a Quality Engineer to lead PFMEA and Test Method Validation (TMV) remediation efforts in a post-acquisition environment. This role focuses on strengthening compliance, risk management, and quality systems.
Key Responsibilities
+ Lead PFMEA remediation and risk assessments
+ Develop and execute Test Method Validations (TMV)
+ Conduct Gage R&R (GR&R) and measurement system analysis
+ Ensure compliance with ISO 13485, ISO 14971, and FDA QSR
+ Partner cross-functionally with Engineering, Quality, and Operations
+ Support audits and QMS integration efforts
Qualifications
+ Bachelor’s in Engineering
+ 5+ years in medical device quality engineering
+ Strong experience with PFMEA, TMV, and statistical analysis
+ Design Quality experience
+ Knowledge of FDA/ISO standards
#ACTservices26Job Type & Location
This is a C...