Remote Lab Quality Engineer - QA, CAPA & Compliance

Insight Global (United States); Atlanta (GA); Remote; USD 99,000 - 100,000; Full time

Benefits offered by this job

Health Insurance

401(k)

Employee Assistance Program (EAP)

Paid time off

Job summary

Insight Global seeks a Lab Quality Engineer to join a US-based team. The role focuses on ensuring quality and compliance of laboratory processes and deliverables, and supporting qualification and validation of lab equipment and software used in product testing.

The position involves cross-functional collaboration, CAPA management, calibration reviews, and validation of non-product systems to meet 21 CFR Part 11 and internal standards.

Qualifications

• M.S. in Mechanical Engineering is required.
• At least 24 months of experience in quality-related engineering roles.
• Experience with risk management and DFMEA/PFMEA.
• Experience with CAPA, regulatory monitoring, and compliance processes.

Responsibilities

• Ensure quality and compliance of laboratory processes and deliverables.
• Support design qualification and validation of lab equipment and software (e.g., dual-axis inclinometers, torque screwdrivers, filtration particle analysis systems).
• Conduct torsional, functional, and fatigue testing of implants and surgical devices.
• Collaborate with cross-functional teams to drive continuous improvement and address non-conformances.
• Perform validation for non-product systems (e.g., Filtrex, Windchill PLM) to meet 21 CFR Part 11 and internal procedures.
• Review calibration histories and qualify MTEs (torque drivers, load frames, optical microscopes).
• Provide CAPA management and risk rationales for equipment with missed calibrations.

Education

M.S. in Mechanical Engineering

Job description

Insight Global seeks a Lab Quality Engineer to join a US-based team. The role focuses on ensuring quality and compliance of laboratory processes and deliverables, and supporting qualification and validation of lab equipment and software used in product testing.

The position involves cross-functional collaboration, CAPA management, calibration reviews, and validation of non-product systems to meet 21 CFR Part 11 and internal standards.