Quality Engineer - Medical Devices | Risk, Validation & QA

Top Quality Recruitment (TQR); Kennesaw (GA); On-site; USD 75,000 - 105,000; Full time

Job summary

Top Quality Recruitment (TQR) is seeking a Quality Engineer to support product development through commercialization and sustainment, collaborating with cross-functional teams to ensure quality and regulatory compliance.

The role involves developing PFMEA, verification/validation plans, and reports, and reviewing designs for manufacturability and reliability. Candidates should have 2+ years in medical device quality and Lean/Six Sigma experience.

Qualifications

• BS in Engineering or Life Sciences; related field and manufacturing/medical device quality experience preferred.
• Minimum of 2+ years of medical device experience preferred.
• Experience with Lean and Six Sigma methodologies.
• Knowledge of regulatory requirements (FDA, Notified Bodies) and risk management standards.

Responsibilities

• Support product life cycle from development to commercialization and sustaining changes.
• Assist in PFMEA development and validation activities.
• Oversee verification and validation test plans, protocols, and reports.
• Ensure compliance with regulatory authorities including FDA and Notified Body.
• Review product designs for manufacturability, reliability, and testability.
• Participate in cross-functional teams to develop risk management files (DFMEA and risk reports).
• Manage multiple projects with detailed tasks and schedules.

Skills

Verbal communication

Written communication

Cross-functional collaboration

Risk management

Education

BS in Engineering or Life Sciences

Associate's degree in Engineering Technology

Tools

ISO 14971

DOE

SPC

IQ/OQ/PQ

Job description

Top Quality Recruitment (TQR) is seeking a Quality Engineer to support product development through commercialization and sustainment, collaborating with cross-functional teams to ensure quality and regulatory compliance.

The role involves developing PFMEA, verification/validation plans, and reports, and reviewing designs for manufacturability and reliability. Candidates should have 2+ years in medical device quality and Lean/Six Sigma experience.