Quality Engineer

Teklabs Inc; Irvine (CA); Sur place; USD 80 000 - 100 000; Plein temps

Résumé du poste

Teklabs Inc in Irvine, CA is seeking a Quality Engineer with expertise in PFMEA and Test Method Validation (TMV) remediation. This role involves leading remediation activities and collaborating across teams to integrate processes into the Quality Management System.

The ideal candidate has over 5 years of experience in the medical device industry, hands-on experience in TMV, and a strong understanding of regulatory compliance. The position is onsite in Irvine, CA, and offers a long-term contract.

Qualifications

• 5+ years of relevant Quality Engineering experience in the medical device industry.
• Proven experience leading PFMEA development and remediation.
• Solid working knowledge of ISO 13485, ISO 14971, and FDA QSR (21 CFR 820).

Responsabilités

• Lead and execute PFMEA remediation activities.
• Own the remediation, development, and documentation of Test Method Validations (TMVs).
• Collaborate cross-functionally with R&D, Manufacturing Engineering, Quality Control, and Operations.

Connaissances

Risk management

Test Method Validation (TMV)

Gage R&R

Quality Engineering

Formation

Bachelor’s degree in Engineering (Biomedical, Mechanical, Manufacturing, Industrial, or related field)

Outils

Minitab

Excel

Description du poste

This role is ideal for a seasoned medical device quality professional with strong expertise inrisk 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 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 and process states
• Own theremediation, development, and documentation ofTestMethod Validations (TMVs) for inspection, test, and measurement methods used in manufacturing and product verification
• Evaluate legacy testmethods for 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 statistical techniques(e.g., GR&R, bias, linearity, stability) to assess measurement system capability and suitability
• Ensure PFMEAs and TMVs comply withISO 14971,ISO 13485, FDA Quality System Regulation (21 CFR 820), and internal quality procedures
• Collaborate cross‑functionally withR&D, Manufacturing Engineering, Quality Control, and Operations to define test requirements, acceptance criteria, and validation strategies
• Support integration of acquired products, processes, and testmethods into the parent company’s QMS
• Review and approve TMV protocols, reports, and supporting statistical analyses
• Facilitate risk management and PFMEA reviews to ensure testmethods 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 testmethod 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 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 and test methods
• Solid working knowledge ofISO 13485,ISO 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 analytical testmethods
• 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