Quality Engineer

Quality Engineer Teklabs Inc Irvine, CA Job Details Full-time 1 day ago Qualifications Inspection gauge Statistics Measurement-based inspection Content creation for technical audiences Technical documentation Quality control statistical data analysis Technical writing within manufacturing Dimensional measurements Bachelor's degree in engineering Production validation processes Quality risk management Medical device manufacturing facility experience Mechanical quality control procedures Leading team collaboration initiatives Regulatory/legal compliance standards in production Biomedical regulatory compliance FMEA Test validation method Cross-functional team management

ISO 13485

Cross-functional communication FDA regulations Full Job Description 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