[Hiring] Lab Quality Engineer @Insight Global

Role Description

Our team is looking for a Lab Quality Engineer.

• 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)
  • 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
  • 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
  • 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
  • Optical microscopes used in GxP testing.
• Providing bounding and risk rationales for equipment with missed calibrations and ensuring 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
  • 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 nonconformance 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 months experience in any Engineering position related to Quality Control.
• 24 months 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

Benefits

• Major medical, dental, and vision insurance.
• Financial protection benefits.
• Pre-tax savings accounts.
• Employee Assistance Program (EAP).
• 401(k).
• PTO/sick leave in accordance with applicable law and company policy.
• 40 hrs/week, 8:00 am – 5:00 pm.
• Salary: $99,382 – $99,383/year.