Kelly Engineering is partnering with a growing medical device company located in the Columbus, OH area on an exciting direct hire Quality Engineer role. This position offers a competitive compensation package, growth potential and a positive team environment.

What you will do:

• Maintain the document control management system, including SOPs and work instructions for document handling per regulations.
• Manage the quality processes for complaints, deviations, CAPA, recalls, and field actions per 21 CFR and ISO 13485; coordinate investigations and implement corrective actions.
• Conduct risk assessments and monitor follow-up activities, ensuring visibility of potential risks.
• Support quality awareness and process improvement; resolve quality issues proactively.
• Work closely with manufacturing and R&D to ensure compliance in product development and production.
• Provide quality support during audits and inspections; establish quality metrics and lead quality initiatives.

Qualifications

• Previous quality experience in medical device manufacturing
• Excellent quantitative and analytical skills.
• Knowledge of 21 CFR and ISO 13485

What happens next:

Once you apply, you’ll proceed to next steps if your skills and experience look like a good fit. But don’t worry – even if this position doesn’t work out, you’re still in the Kelly Engineering network. That means our team of expert engineering recruiters will have access to your profile, making your opportunities limitless