This role is ideal for a seasoned medical device quality professional with strong expertise in risk management,testmethod 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 &TestMethod Validation (TMV) Remediation (2 Openings)Location: Irvine, CA (Onsite)Industry: Medical DevicesEmployment Type: Long term contractKey ResponsibilitiesLead and execute PFMEA remediation activities, including gap assessments, risk re‑evaluations, updates, and alignment to current manufacturing and process statesOwn the remediation, development, and documentation ofTestMethod Validations (TMVs) for inspection, test, and measurement methods used in manufacturing and product verificationEvaluate legacy testmethods for adequacy, robustness, and regulatory compliance; identify gaps and define remediation plansPlan, execute, and review Gage Repeatability & Reproducibility (Gage R&R / GR&R) studies as part of TMV and measurement system validation activitiesApply statistical techniques(e.g., GR&R, bias, linearity, stability) to assess measurement system capability and suitabilityEnsure PFMEAs and TMVs comply with ISO 14971, ISO 13485, FDA Quality System Regulation (21 CFR 820), and internal quality proceduresCollaborate cross‑functionally with R&D, Manufacturing Engineering, Quality Control, and Operations to define test requirements, acceptance criteria, and validation strategiesSupport integration of acquired products, processes, and testmethods into the parent company's QMSReview and approve TMV protocols, reports, and supporting statistical analysesFacilitate risk management and PFMEA reviews to ensure testmethods adequately detect and control product and process risksEnsure TMV and PFMEA changes are properly documented and implemented through formal change control processesSupport internal and external audits, inspections, and diligence activities related to test method validation and measurement systemsIdentify opportunities to improve testmethod robustness and long‑term sustainment of validation practicesRequired QualificationsBachelor's degree in Engineering (Biomedical, Mechanical, Manufacturing, Industrial, or related field)5+ years of relevant Quality Engineering experience in the medical device industryProven experience leading PFMEA development and remediationStrong hands‑on experience with TestMethod Validation (TMV)Required familiarity and working knowledge of Gage R&R (GR&R) and measurement system analysisAbility to interpret and apply statistical data to validate inspection and test methodsSolid working knowledge of ISO 13485, ISO 14971, and FDA QSR (21 CFR 820)Experience supporting remediation efforts in a post‑acquisition or compliance-driven environmentAbility to work onsite in Irvine, CAExcellent technical writing, analytical, and documentation skillsAbility to work independently and effectively lead cross‑functional teamsPreferred QualificationsExperience validating mechanical, dimensional, functional, or analytical testmethodsProficiency with statistical software or analysis tools (e.g., Minitab, JMP, Excel)Experience supporting FDA inspections and/or notified body auditsUnderstanding of verification and validation (V&V) activities and their linkage to risk managementExperience with electronic QMS systems (e.g., Agile, Windchill, Arena, MasterControl)Background in medical device manufacturing, inspection, or metrology#J-18808-Ljbffr.