Quality Engineer - Medical Devices, Risk & Validation

Top Quality Recruitment (TQR); Kennesaw (GA); On-site; USD 70,000 - 95,000; Full time

Job summary

Top Quality Recruitment (TQR) is seeking a Quality Engineer to support quality engineering activities across the product life cycle, from NPD through commercialization and sustaining changes. The role involves cross-functional collaboration to ensure regulatory compliance with FDA and Notified Bodies.

Responsibilities include developing PFMEA/IQ/OQ/PQ plans, verification/validation testing, and risk management activities.

Qualifications

• BS in Engineering or Life Sciences or related field.
• Minimum 2+ years of medical device experience preferred.
• Lean and Six Sigma experience preferred.
• Knowledge of regulatory requirements (FDA, Notified Body) desirable.

Responsibilities

• Support quality engineering activities across product life cycle from concept to commercialization.
• Develop and oversee PFMEA, IQ, OQ, PQ validation plans and reports.
• Review designs for manufacturability, serviceability and testability.
• Assist risk management activities including dfMEA and risk reports.
• Collaborate with cross-functional teams to manage multiple projects with minimal supervision.
• Contribute to protocol development, verification and validation testing.

Education

Bachelor's degree in Engineering or Life Sciences

Associate's degree in Engineering Technology or related discipline

Tools

PFMEA

Job description

Top Quality Recruitment (TQR) is seeking a Quality Engineer to support quality engineering activities across the product life cycle, from NPD through commercialization and sustaining changes. The role involves cross-functional collaboration to ensure regulatory compliance with FDA and Notified Bodies.

Responsibilities include developing PFMEA/IQ/OQ/PQ plans, verification/validation testing, and risk management activities.