Quality Engineer — PFMEA & TMV Remediation

Teklabs Inc; Irvine (CA); On-site; USD 80,000 - 100,000; Full time

Job summary

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).

Responsibilities

• 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.

Skills

Risk management

Test Method Validation (TMV)

Gage R&R

Quality Engineering

Education

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

Tools

Minitab

Excel

Job description

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.