Quality Assurance Engineer – Medical Devices & Compliance

Inteplast Group; Northern (KY); Hybrid; USD 65,000 - 90,000; Full time

Job summary

Inteplast Group seeks a Quality Assurance Engineer to support regulatory compliance, quality systems, and continuous improvement for medical devices. The role involves developing and maintaining quality programs under FDA and Health Canada guidance, and assisting with audits and corrective actions.

The position requires a engineering or business background, 2–4 years of QA in medical devices, and familiarity with ISO 13485 and FDA QSR.

Qualifications

• Bachelor's degree in industrial engineering, mechanical engineering, or business from an accredited four-year college is preferred.

Responsibilities

• Assist QA and Regulatory Affairs Manager in developing and maintaining a compliant quality management system for medical products.

Skills

Quality Assurance

Regulatory compliance

Statistical techniques

Team leadership

Education

Bachelor's degree in industrial engineering or mechanical engineering or business

Associate's degree or equivalent + 2-4 years QA experience

Tools

SAP

Job description

Inteplast Group seeks a Quality Assurance Engineer to support regulatory compliance, quality systems, and continuous improvement for medical devices. The role involves developing and maintaining quality programs under FDA and Health Canada guidance, and assisting with audits and corrective actions.

The position requires a engineering or business background, 2–4 years of QA in medical devices, and familiarity with ISO 13485 and FDA QSR.