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Medical Device Quality Engineer Columbus, OH

Job in Columbus, Franklin County, Ohio, 43224, USA
Listing for: Omni One
Full Time position
Listed on 2026-05-30
Job specializations:
  • Engineering
    Quality Engineering, Biomedical Engineer
  • Quality Assurance - QA/QC
    Quality Engineering
Salary/Wage Range or Industry Benchmark: 90000 - 110000 USD Yearly USD 90000.00 110000.00 YEAR
Job Description & How to Apply Below
Position: Medical Device Quality Engineer at Omni One Columbus, OH

Medical Device Quality Engineer

Location:

Columbus, OH

Salary: $90,000 - $110,000

Posted:
Aug 21, 2025

Our client is a leading medical device manufacturer in Central Ohio seeking a Quality Engineer for a full‑time, direct hire position.

Responsibilities
  • Ensure quality and regulatory requirements are met for all company products
  • Maintain QMS records for ISO 13485 and medical device regulations
  • Perform root‑cause analysis and implement corrective actions
  • Conduct internal, external, and FDA audits
  • Validate equipment, including IQ/OQ/PQ
  • Implement risk management procedures
  • Create and implement processes to increase efficiency and effectiveness
  • Support long‑term quality, regulatory, and compliance policies
Qualifications
  • B.S. degree in an engineering discipline (preferred)
  • Minimum 3+ years of experience in an ISO 13485 and FDA‑regulated medical device industry
  • Ability to travel 10–15% of the time to other facility locations
  • Strong attention to detail, accuracy, and organization
  • Strong analytical and problem‑solving skills
  • ASQ certification preferred
  • Excellent verbal and written communication skills
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