Medical Device Quality Engineer - Regulatory & Process

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

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.