Quality Engineer I

Owens & Minor

Toano, Virginia, United States
Base: $70,000 annually; bonus/equity: not specifie...
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Fda 21 cfr part 820 compliance
Iso 13485 regulatory standards
Sterilization process validation
** Owens & Minor is seeking a Quality Engineer I to ensure compliance with its Quality Management System in a medical device manufacturing environment in Toano, Virginia. The role involves coordinating quality systems, conducting validations, and working cross-functionally to maintain compliance with regulatory standards. **

Job Summary

  • The role ensures compliance with FDA and ISO standards while supporting medical device manufacturing for custom procedure trays.
  • Owens & Minor offers comprehensive benefits including healthcare starting day one, educational assistance, and paid parental leave.
  • This position requires coordinating cross-functionally with Maintenance, Sterility Assurance, and Engineering to maintain validated states.

Matching Summary

Match Score: 75

** Owens & Minor is seeking a Quality Engineer I to ensure compliance with its Quality Management System in a medical device manufacturing environment in Toano, Virginia. The role involves coordinating quality systems, conducting validations, and working cross-functionally to maintain compliance with regulatory standards. **

Salary

Base: $70,000 annually; Bonus/Equity: Not specified; Benefits: Comprehensive Healthcare, Educational Assistance, 401(k)

Skills & Requirements

Must-have

  • FDA 21 CFR Part 820 compliance
  • ISO 13485 regulatory standards
  • Sterilization process validation
  • Master Validation Plan management
  • Environmental monitoring procedures
  • Statistical analysis with Minitab

Nice-to-have

  • Lean Six Sigma training
  • Internal auditor certification
  • Cross-functional team leadership
  • Problem-solving techniques
  • Continuous improvement mindset

Key Requirements

  • Bachelor's degree in Engineering or equivalent experience
  • 3 to 5 years of manufacturing environment experience
  • At least 1 year in FDA regulated industry
  • At least 1 year leading teams
  • Knowledge of calibration and pest control programs

Work Rights

Not specified

Tailored Resume

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