Quality Engineer

This role is ideal for a seasoned medical device quality professional with strong expertise inrisk managementtestmethod validation and measurement system analysis capable of independently assessing legacy documentation developing remediation strategies and collaborating crossfunctionally to integrate acquired products and processes into an established Quality Management System (QMS).

• Job Title: Quality Engineer PFMEA &TestMethod Validation (TMV) Remediation (2 Openings)
• Location:Irvine CA (Onsite)
• Industry:Medical Devices
• Employment Type:Long term contract

Key Responsibilities

• Lead and executePFMEA remediation activities including gap assessments risk re-evaluations updates and alignment to current manufacturing andprocessstates
• Own theremediation development and documentation ofTestMethod Validations (TMVs)for inspectiontest and measurementmethodsused in manufacturing and product verification
• Evaluate legacytestmethodsfor adequacy robustness and regulatory compliance; identify gaps and define remediation plans
• Plan execute and reviewGage Repeatability & Reproducibility (Gage R&R / GR&R)studies as part of TMV and measurement system validation activities
• Apply statisticaltechniques(e.g. GR&R bias linearity stability) to assess measurement system capability and suitability
• Ensure PFMEAs and TMVs comply withISO 14971ISO 13485 FDA Quality System Regulation (21 CFR 820) and internal qualityprocedures
• Collaborate cross-functionally withR&D Manufacturing Engineering Quality Control and Operationsto definetestrequirements acceptance criteria and validation strategies
• Support integration of acquired products processes andtestmethodsinto the parent companys QMS
• Review and approve TMV protocols reports and supporting statistical analyses
• Facilitate risk management and PFMEA reviews to ensuretestmethodsadequately detect and control product andprocessrisks
• Ensure TMV and PFMEA changes are properly documented and implemented through formal change control processes
• Support internal and external audits inspections and diligence activities related totestmethod validation and measurement systems
• Identify opportunities to improvetestmethod robustness and long-term sustainment of validation practices

Required Qualifications

• Bachelors degree in Engineering (Biomedical Mechanical Manufacturing Industrial or related field)
• 5 years of relevant Quality Engineering experience in the medical device industry
• Proven experience leadingPFMEA development and remediation
• Strong hands-on experience withTestMethod Validation (TMV)
• Required familiarity and working knowledge of Gage R&R (GR&R) and measurement system analysis
• Ability to interpret and apply statistical data to validate inspection andtestmethods
• Solid working knowledge ofISO 13485ISO 14971 and FDA QSR (21 CFR 820)
• Experience supporting remediation efforts in apost-acquisition or compliance-driven environment
• Ability to workonsite in Irvine CA
• Excellent technical writing analytical and documentation skills
• Ability to work independently and effectively lead cross-functional teams

Preferred Qualifications

• Experience validating mechanical dimensional functional or analyticaltestmethods
• Proficiency with statistical software or analysis tools (e.g. Minitab JMP Excel)
• Experience supporting FDA inspections and/or notified body audits
• Understanding of verification and validation (V&V) activities and their linkage to risk management
• Experience with electronic QMS systems (e.g. Agile Windchill Arena MasterControl)
• Background in medical device manufacturing inspection or metrology