Quality Engineer - Medical Devices & Compliance Impact

Abrasive Technology, Ltd.; Lewis Center (OH); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

Company paid life insurance

Disability insurance

401k with company match

Quarterly incentive bonuses

Flexible hours

Paid time off

December plant shutdown

Job summary

Abrasive Technology is seeking a Quality Engineer to join our Medical Products team and help assure the delivery of high-quality medical devices used in critical applications worldwide.

You will collaborate across engineering, manufacturing, and operations to drive continuous improvement, perform root cause analysis, and support regulatory compliance. This role emphasizes cross-functional teamwork and a strong commitment to ethics and quality.

Qualifications

• Five+ years of quality engineering experience.
• Experience applying quality requirements in medical device environments.
• Experience with ISO 9001/13485, regulatory standards preferred.

Responsibilities

• Ensure compliance with ISO 9001, ISO 14971, ISO 13485 and MDSAP.
• Improve Cost of Quality for the medical business segment.
• Serve as the primary medical product quality contact for external customers.
• Ensure quality/design requirements are met on time.
• Lead root cause analysis and corrective action teams.
• Develop and execute internal audits for customer standards.
• Perform full Quality Engineering functions including supporting manufacturing.
• Recommend and implement quality improvements and new systems.

Skills

Quality engineering experience

Regulatory compliance

Project management

Ethical conduct

Analytical thinking

Education

BS in Engineering/Engineering Technology

Job description

Abrasive Technology is seeking a Quality Engineer to join our Medical Products team and help assure the delivery of high-quality medical devices used in critical applications worldwide.

You will collaborate across engineering, manufacturing, and operations to drive continuous improvement, perform root cause analysis, and support regulatory compliance. This role emphasizes cross-functional teamwork and a strong commitment to ethics and quality.