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

Overview

Our team is looking for a Lab Quality Engineer.

Responsibilities

Responsibilities include: Ensuring the quality and compliance of our laboratory processes and deliverables. Supporting the design qualification and validation of laboratory equipment and software used in product testing, including dual-axis inclinometers, torque screwdrivers, filtration particle analysis systems (e.g., Scanning electron microscopic software), and custom-built orthopedic testing fixtures. Conducting torsional, functional, and fatigue testing of implants and surgical devices. Collaborating with cross-functional teams, including Test Engineers, Material Scientists, and R&D Engineers, to maintain high quality standards and drive continuous improvement. Identifying and addressing non-conformances within our processes, ensuring corrective and preventive actions (CAPA) are implemented effectively. Conducting validation for non-product systems such as Filtrex particle analysis software, Windchill PLM, and other quality tools to ensure compliance with 21 CFR Part 11 and internal procedures. Providing quality review and approving deliverables related to test methods, test method validations, instrument qualifications, and software validations. Providing Calibration and Equipment Qualification. Reviewing calibration histories, performing gap assessments, and ensuring qualification of measuring and test equipment (MTE) such as torque drivers, load frames, and optical microscopes used in GxP testing. Providing bounding and risk rationales for equipment with missed calibrations and ensure no product impact. Staying informed about current ASTM/ISO test standards, regulatory guidelines, and ISO 17025 accreditation. Working on Change Control and Document Management. Reviewing and approving changes to controlled documents, including spreadsheets, forms, and laboratory test methods. Ensuring compliance with Good Documentation Practices (GDP) and addressing discrepancies such as incorrect revision markings or clerical errors in controlled documents. Documenting Nonconformance and CAPA Management. Investigating nonconformances issues related to test methods, software, and laboratory equipment (e.g., missed calibrations, inconsistent statistical outputs in validated spreadsheets). Using root cause analysis, statistical methods, and cross-functional reviews to develop corrective and preventive actions. Working closely with other Quality Engineers, Quality Systems, and various functions to complete assigned activities. Assisting Worldwide test lab and support locations across the US and Europe. Telecommuting permitted. Work may occur from anywhere within the U.S.

Qualifications

M.S. in Mechanical Engineering or closely related. 24 mo. exp in any Engineering position related to Quality Control. 24 mon. in: Risk Management; DFMEA/PFMEA Corrective Actions; Audit & Inspection Readiness; PMS Documentation; Post-Market Failure Mode Evaluation; Root Cause Analysis to support design/process changes; Regulatory Intelligence & Compliance Monitoring; Compliance Gaps; CAPAs & Compliance Closure. Insight Global offers major medical, dental, and vision insurance in addition to financial protection benefits, pre-tax savings accounts, an Employee Assistance Program (EAP), and 401(k). PTO/ sick leave in accordance with applicable law and company policy. 40 hrs/wk. 8:00 am – 5:00 pm. $99,382 – 99,383/year.

Responsibilities include: Ensuring the quality and compliance of our laboratory processes and deliverables. Supporting the design qualification and validation of laboratory equipment and software used in product testing, including dual-axis inclinometers, torque screwdrivers, filtration particle analysis systems (e.g., Scanning electron microscopic software), and custom-built orthopedic testing fixtures. Conducting torsional, functional, and fatigue testing of implants and surgical devices. Collaborating with cross-functional teams, including Test Engineers, Material Scientists, and R&D Engineers, to maintain high quality standards and drive continuous improvement. Identifying and addressing non-conformances within our processes, ensuring corrective and preventive actions (CAPA) are implemented effectively. Conducting validation for non-product systems such as Filtrex particle analysis software, Windchill PLM, and other quality tools to ensure compliance with 21 CFR Part 11 and internal procedures. Providing quality review and approving deliverables related to test methods, test method validations, instrument qualifications, and software validations. Providing Calibration and Equipment Qualification. Reviewing calibration histories, performing gap assessments, and ensuring qualification of measuring and test equipment (MTE) such as torque drivers, load frames, and optical microscopes used in GxP testing. Providing bounding and risk rationales for equipment with missed calibrations and ensure no product impact. Staying informed about current ASTM/ISO test standards, regulatory guidelines, and ISO 17025 accreditation. Working on Change Control and Document Management. Reviewing and approving changes to controlled documents, including spreadsheets, forms, and laboratory test methods. Ensuring compliance with Good Documentation Practices (GDP) and addressing discrepancies such as incorrect revision markings or clerical errors in controlled documents. Documenting Nonconformance and CAPA Management. Investigating nonconformances issues related to test methods, software, and laboratory equipment (e.g., missed calibrations, inconsistent statistical outputs in validated spreadsheets). Using root cause analysis, statistical methods, and cross-functional reviews to develop corrective and preventive actions. Working closely with other Quality Engineers, Quality Systems, and various functions to complete assigned activities. Assisting Worldwide test lab and support locations across the US and Europe. Telecommuting permitted. Work may occur from anywhere within the U.S.

M.S. in Mechanical Engineering or closely related. 24 mo. exp in any Engineering position related to Quality Control. 24 mon. in: Risk Management; DFMEA/PFMEA Corrective Actions; Audit & Inspection Readiness; PMS Documentation; Post-Market Failure Mode Evaluation; Root Cause Analysis to support design/process changes; Regulatory Intelligence & Compliance Monitoring; Compliance Gaps; CAPAs & Compliance Closure. Insight Global offers major medical, dental, and vision insurance in addition to financial protection benefits, pre-tax savings accounts, an Employee Assistance Program (EAP), and 401(k). PTO/ sick leave in accordance with applicable law and company policy. 40 hrs/wk. 8:00 am – 5:00 pm. $99,382 – 99,383/year.