Medical Device Quality Engineer — ISO 13485 & FDA Audits

Medical Device Quality Engineer job at Omni One. Columbus, OH.Medical Device Quality Engineer Posted OnAug 21, 2025

Location Columbus ,Ohio Salary $90,000-$110,000

Status Full Time Job ID28872

Medical Device Quality Engineer
Columbus, OH
$90,000 - $110,000
28872

Our client is a successful manufacturer who has continued to grow and expand their central Ohio footprint. They are currently searching for a talented Quality Engineer. This is a full-time/direct hire opening. They were founded in the early 1900’s and have grown to be the industry leader for products that help people every day.

Why Apply:

• Tremendous job stability
• Awesome opportunity for growth and career achievement
• Tremendous benefits including great match on 401(k), no vesting period for 401(k), onsite gymnasium, low-cost/great coverage insurance, and more

• 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
• Perform internal, external, and FDA audits
• Equipment validation, IQ/OQ/PQ
• Implement risk management procedures
• Create and implement processes for increased efficiency and effectiveness
• Support long-term quality, regulatory, and compliance policies

• B.S. degree in an engineering discipline preferred
• Minimum of 3+ years of experience required in an ISO 13485 and FDA regulated medical device industry
• Ability to travel approximately 10-15% of the time to other facility locations
• Must have a high level of attention to detail, accuracy, organization
• Strong analytical and problem-solving skills
• ASQ certification preferred
• Excellent communication skills both verbal and written

Please fill out the form below to submit your application.