Quality Engineer

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).

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

Key Responsibilities

• Lead and execute  PFMEA remediation activities , including gap assessments, risk re-evaluations, updates, and alignment to current manufacturing and process states
• Own the  remediation, development, and documentation of Test Method Validations (TMVs) for inspection, test, and measurement methods used in manufacturing and product verification
• Evaluate legacy test methods for adequacy, robustness, and regulatory compliance; identify gaps and define remediation plans
• Plan, execute, and review  Gage Repeatability & Reproducibility (Gage R&R / GR&R) studies as part of TMV and measurement system validation activities
• Apply statistical techniques (e.g., GR&R, bias, linearity, stability) to assess measurement system capability and suitability
• Ensure PFMEAs and TMVs comply with  ISO 14971 ,  ISO 13485 , FDA Quality System Regulation (21 CFR 820), and internal quality procedures
• Collaborate cross-functionally with  R&D, Manufacturing Engineering, Quality Control, and Operations to define test requirements, acceptance criteria, and validation strategies
• Support integration of acquired products, processes, and test methods into the parent company’s QMS
• Review and approve TMV protocols, reports, and supporting statistical analyses
• Facilitate risk management and PFMEA reviews to ensure test methods adequately detect and control product and process risks
• 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 to test method validation and measurement systems
• Identify opportunities to improve test method robustness and long-term sustainment of validation practices

Required Qualifications

• Bachelor’s degree in Engineering (Biomedical, Mechanical, Manufacturing, Industrial, or related field)
• 5+ years of relevant Quality Engineering experience in the medical device industry
• Proven experience leading  PFMEA development and remediation
• Strong hands-on experience with  Test Method 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 and test methods
• Solid working knowledge of  ISO 13485 ,  ISO 14971 , and FDA QSR (21 CFR 820)
• Experience supporting remediation efforts in a  post-acquisition or compliance-driven environment
• Ability to work  onsite 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 analytical test methods
• 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