Quality Assurance Engineer (medical Device Manufacture)

Quality Assurance Engineer

Our client, a well-established medical device manufacturer specializing in plastic medical products, is seeking a Quality Assurance Engineer to join their team in Galloway, Tennessee. This is an exciting opportunity to build and strengthen a critical quality function within an FDA-regulated manufacturing environment.

The company manufactures Class I and II medical device products including biohazard containment, patient care items, and sterile packaging solutions through plastic injection molding and bag manufacturing processes. With facilities across multiple states and a strong parent company backing, this role offers genuine growth potential and the chance to make a meaningful impact on quality systems and regulatory compliance.

Key Responsibilities

• Support the development and maintenance of a comprehensive Quality Management System (QMS) compliant with FDA 21 CFR Part 820 (QSR) and ISO 13485:2016 standards for Class I and II medical devices
• Lead and participate in internal and external quality audits, ensuring readiness for FDA, Health Canada, and other regulatory inspections
• Manage CAPA (Corrective and Preventive Action) systems, including root cause analysis, investigation of customer complaints, and effectiveness verification
• Oversee sterilization validation and compliance for contract-sterilized medical device products
• Provide quality engineering support to production, including product specification development, continuous evaluation, and data analysis to ensure products meet intended use
• Serve as quality liaison with customers and vendors on quality-related matters
• Deliver training to cross-functional teams on statistical techniques, quality science, and regulatory requirements
• Supervise and direct Quality Assurance Analysts and Auditors in day-to-day quality assurance activities
• Ensure compliance with FDA, Health Canada, AAMI sterilization standards, OSHA, EPA, and other applicable regulatory requirements
• Support continuous improvement initiatives across manufacturing operations