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Medical Device Quality Engineer

Company:
Omni One
Location:
Columbus, OH
Pay:
90000USD - 110000USD per year
Posted:
August 25, 2025
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Description:

Job Description

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

The current opening is for a Quality Engineer. Main duties include:

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

Qualifications include:

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 apply or send us a copy of your resume to . All of your information will be kept confidential. Please feel free to call us at .

Applications that fit the listed requirements will be contacted within 2-3 business days to schedule an initial phone interview with the Omni One team.Company Description

Omni One specializes in engineering, professional, and technical staffing (no cost to you!). We work with a broad range of engineers, manufacturing, and technical skilled applicants throughout the United States. We strive to help each applicant and client shape their future and reach their goals.

Full-time

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