Medical Device Quality Engineer

Omni One; Columbus (OH); On-site; USD 90,000 - 110,000; Full time

Benefits offered by this job

401(k) with great match

Onsite gymnasium

Comprehensive medical insurance

Job summary

A leading manufacturing company in Columbus, OH is seeking a Quality Engineer to ensure compliance with regulatory requirements for medical devices. This is a full-time role requiring 3+ years of experience in ISO 13485 and FDA compliance. Ideal candidates will have strong analytical skills, attention to detail, and excellent communication abilities. The role offers competitive benefits including a 401(k) match and medical coverage.

Qualifications

• Minimum of 3+ years of experience in ISO 13485 and FDA regulated medical device industry.
• Must have strong analytical and problem-solving skills.
• ASQ certification preferred.

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.

Skills

Attention to detail

Problem-solving skills

Communication skills

Education

B.S. degree in an engineering discipline

Tools

ISO 13485

FDA regulations

Job description

Medical Device Quality Engineer

This range is provided by Omni One. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$90,000.00/yr - $110,000.00/yr

Direct message the job poster from Omni One

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
• 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 [e-mail]. All of your information will be kept confidential. Please feel free to call us at 614-760-5799.

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.

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Full-time

Job function

• Job function

  Manufacturing

• Industries

  Manufacturing

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

Disability insurance

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