Medical QA Engineer: Elevate Quality & Compliance

Abrasive Technology Inc; Lewis Center (OH); On-site; USD 90,000 - 110,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

Company paid life insurance

Short-term disability

Long-term disability

401k with company match

Quarterly incentive bonuses

Flexible hours

Paid time off

Plant shutdown in December

Job summary

Abrasive Technology in Lewis Center, OH is seeking a Quality Assurance Engineer for Medical products. The role focuses on ensuring stringent quality across engineering, manufacturing, and operations, driving continuous improvement and regulatory compliance to support critical medical applications worldwide.

You will lead audits, root-cause investigations, and cross-functional quality initiatives, working in a fast-paced manufacturing environment to deliver high-quality medical tools and devices.

Qualifications

• BS Degree in Engineering/Engineering Technology or equivalent experience.
• Minimum of 5 years Quality Engineering experience.
• Experience in medical product/manufacturing environment and regulatory requirements.
• Experience applying quality requirements to medical devices.

Responsibilities

• Ensure compliance with ISO 9001, ISO 14971, ISO 13485 and MDSAP across the department.
• Manage and improve Cost of Quality for the medical segment.
• Serve as primary medical product customer quality assurance contact for external customers.
• Ensure quality and design requirements are executed on time.
• Lead root cause analysis and corrective action for quality issues.
• Develop and execute internal auditing processes for ongoing compliance.
• Support manufacturing, training, material certification review, and root cause analysis.

Skills

Quality Engineering

Project management

Regulatory compliance

Root cause analysis

Medical device familiarity

Education

BS Degree in Engineering/Engineering Technology

Job description

Abrasive Technology in Lewis Center, OH is seeking a Quality Assurance Engineer for Medical products. The role focuses on ensuring stringent quality across engineering, manufacturing, and operations, driving continuous improvement and regulatory compliance to support critical medical applications worldwide.

You will lead audits, root-cause investigations, and cross-functional quality initiatives, working in a fast-paced manufacturing environment to deliver high-quality medical tools and devices.