Lab Quality Engineer (Atlanta, GA, or other unanticipated locations throughout U.S.)

Insight Global•Dunwoody, GA

20h•Remote

About The Position

The Lab Quality Engineer ensures the quality and compliance of laboratory processes and deliverables. The role supports design qualification and validation of laboratory equipment and software used in product testing, and conducts torsional, functional, and fatigue testing of implants and surgical devices. The engineer collaborates with Test Engineers, Material Scientists, R&D Engineers, Quality Engineers, Quality Systems, and other functions to maintain quality standards and drive continuous improvement. The position provides quality review and approval for test methods, test method validations, instrument qualifications, and software validations. It also covers calibration and equipment qualification, controlled-document change management, nonconformance investigations, and CAPA management. The engineer supports worldwide test laboratories and support locations in the U.S. and Europe. Telecommuting is permitted, and work may be performed from anywhere within the U.S. The schedule is 40 hours per week, 8:00 a.m. to 5:00 p.m.

Requirements

Master’s degree in Mechanical Engineering or a closely related field.
At least 24 months of experience in an engineering position related to Quality Control.
At least 24 months of experience in risk management; DFMEA/PFMEA corrective actions; audit and inspection readiness; PMS documentation; post-market failure mode evaluation; root cause analysis supporting design or process changes; regulatory intelligence and compliance monitoring; compliance gaps; and CAPAs and compliance closure.

Responsibilities

Ensure the quality and compliance of laboratory processes and deliverables.
Support design qualification and validation of laboratory equipment and software used in product testing.
Conduct torsional, functional, and fatigue testing of implants and surgical devices.
Collaborate with Test Engineers, Material Scientists, R&D Engineers, Quality Engineers, Quality Systems, and other functions to maintain quality standards and drive continuous improvement.
Identify and address process nonconformances and ensure corrective and preventive actions are implemented effectively.
Validate non-product systems, including Filtrex particle analysis software, Windchill PLM, and other quality tools, for compliance with 21 CFR Part 11 and internal procedures.
Review and approve deliverables related to test methods, test method validations, instrument qualifications, and software validations.
Provide calibration and equipment qualification, review calibration histories, perform gap assessments, and ensure qualification of measuring and test equipment used in GxP testing.
Provide bounding and risk rationales for equipment with missed calibrations and ensure there is no product impact.
Stay informed about current ASTM and ISO test standards, regulatory guidelines, and ISO 17025 accreditation.
Review and approve changes to controlled documents, including spreadsheets, forms, and laboratory test methods.
Ensure compliance with Good Documentation Practices and address controlled-document discrepancies, such as incorrect revision markings or clerical errors.
Investigate nonconformances involving test methods, software, and laboratory equipment, using root cause analysis, statistical methods, and cross-functional reviews to develop corrective and preventive actions.
Assist worldwide test laboratory and support locations across the U.S. and Europe.