Quality Engineer I

Owens & Minor

Toano, VA, United States
Base: $70,000; bonus/equity: not specified; benefi...
On-site
Quality management system (qms) compliance
Medical device manufacturing support
Sterilization process validations
Owens & Minor is seeking a Quality Engineer I for their Toano, VA location to ensure compliance with quality management systems in medical device manufacturing, particularly related to Custom Procedure Trays. The ideal candidate will have a bachelor's degree in engineering, experience in regulated industries, and strong problem-solving skills

Job Summary

  • Responsible for assuring compliance with the Quality Management System (QMS) by coordinating and maintaining quality systems related to Environmental Monitoring, Pest Control, Calibration, Preventive Maintenance oversight, Master Validation Plan (MVP), and Sterility Assurance support.
  • Supports medical device manufacturing with a primary focus on Custom Procedure Trays (kitting operations) and ensures compliance with applicable regulatory and international standards including FDA 21 CFR Part 820, ISO 13485, and applicable sterilization standards.
  • The anticipated salary for this position is $70,000 annually, with comprehensive benefits including healthcare, educational assistance, and paid leave.

Matching Summary

Match Score: 85

Owens & Minor is seeking a Quality Engineer I for their Toano, VA location to ensure compliance with quality management systems in medical device manufacturing, particularly related to Custom Procedure Trays. The ideal candidate will have a bachelor's degree in engineering, experience in regulated industries, and strong problem-solving skills.

Salary

Base: $70,000; Bonus/Equity: Not specified; Benefits: Comprehensive Healthcare Plan, Educational Assistance, Employer-Paid Life Insurance and Disability, Voluntary Supplemental Programs, Support for Growing Family, Health Savings Account (HSA) and 401(k), Paid Leave, Well-Being Programs

Skills & Requirements

Must-have

  • Quality Management System (QMS) compliance
  • Medical device manufacturing support
  • Sterilization process validations
  • Environmental monitoring and control
  • Calibration and preventive maintenance oversight

Nice-to-have

  • Cross-functional collaboration
  • Continuous improvement initiatives
  • Regulatory compliance expertise

Key Requirements

  • Bachelors degree in Engineering or equivalent experience
  • 3 to 5 years in manufacturing environments
  • At least 1 year of experience in highly regulated industry
  • At least 1 year of experience leading teams
  • ISO 13485 and 21 CFR part 820 knowledge

Work Rights

Not specified

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