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