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MillenniumSoft Inc Logo MillenniumSoft Inc · Quality Control

Quality Engineer 2

United States, Sparks Employment contract 56.55 - 63.80 USD / Hour · Job Posted June 30, 2026
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Job Description

Quality Engineer II is responsible for ensuring product and process compliance with quality systems across instrument platforms. The role involves sustaining activities such as complaint handling, nonconformances, CAPAs, change controls, deviation waivers, and audit support. Frequent cross-functional collaboration with R&D, Operations, and other departments is expected. The position contributes to ISO and regional regulatory compliance throughout the product life cycle.

Job Responsibility

  • Support one or more instrument platforms on sustaining quality activities including complaints, nonconformances, CAPAs, change controls, and deviation waivers
  • Maintain ISO and regional regulatory compliance requirements
  • Develop and maintain Device History Files per regulatory requirements
  • Generate CTQ (Critical to Quality) indices and share quality data with project teams, operations, and suppliers
  • Support new product integration into Manufacturing/Operations
  • Perform trend analysis, risk management (FMEA, Hazard Analysis, Fault Tree), and Six Sigma tools
  • Lead root cause investigations for moderately complex issues
  • Ensure divisional and departmental policies, procedures, and facilities comply with applicable regulations
  • Support and actively participate in audits
  • Coach and guide others on quality systems and procedures
  • Interact regularly with cross-functional teams (R&D, Operations, etc.)

Requirements

  • 0- 5 years of experience in a quality engineering or related role
  • Experience using statistical methods required
  • Knowledge of quality systems regulations, ISO Quality System, and Medical Device standards
  • Microsoft Office Suite - strong Excel skills (data extraction & analysis)
  • Six Sigma tools
  • Data collection, analysis, and reporting
  • Strong verbal and written communication
  • Time management and ability to handle multiple tasks independently
  • Ability to work independently and within large multifunctional teams
  • Strong attention to detail and accuracy
  • Self-motivated, organized, and detail-oriented

Nice to have

  • Familiarity with medical device manufacturing processes preferred
  • Experience with Design Control requirements and Medical Device Validations preferred
  • SAP proficiency strongly preferred
  • Knowledge of biological/chemical test methods preferred
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