Quality Engineer I

Byram Healthcare Centers Inc

Toano, VA, United States
Base: $70,000 annually; bonus/equity: not specifie...
Onsite
Quality management system (qms)
Environmental monitoring
Sterility assurance support
This position 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

Job Summary

  • This position 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 incumbent applies quality engineering principles to support sterilization process validations, requalification’s, and evaluations, ensuring the continued effectiveness of sterile barrier systems and sterilization controls.
  • Comprehensive Healthcare Plan - Medical, dental, and vision plans start on day one of employment for full-time teammates.

Matching Summary

This position 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.

Salary

Base: $70,000 annually; Bonus/Equity: Not specified; Benefits: Comprehensive Healthcare Plan, Educational Assistance, Employer-Paid Life Insurance and Disability, Voluntary Supplemental Programs, Adoption assistance, fertility benefits, parental leave, Health Savings Account (HSA) and 401(k), Paid Leave, Teammate Assistance Program (TAP), Calm Health, Cancer Resources Services, and discount programs

Skills & Requirements

Must-have

  • Quality Management System (QMS)
  • Environmental Monitoring
  • Sterility Assurance support
  • medical device manufacturing
  • statistical techniques to analyze data
  • ISO 13485 and 21 CFR part 820

Nice-to-have

  • lean six-sigma
  • ISO 13485 Internal auditor training
  • leading teams
  • cross functional teams
  • EHS guidelines

Key Requirements

  • Bachelors degree in Engineering or equivalent experience
  • 3 to 5 years on manufacturing environments
  • At least 1 year of experience on highly regulated industry
  • At least 1 year of experience on leading teams
  • Proven skills on Problem solving techniques
  • High knowledge on developing and technical documents and reports

Work Rights

Not specified

Tailored Resume

Cover Letter