Quality Assurance Engineer (Medical Device Manufacture)

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 a 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

• Bachelor's degree in Industrial Engineering, Mechanical Engineering, or Quality from an accredited institution
• Experience with plastic injection molding and/or blow molding manufacturing processes
• ISO 13485:2016 Lead Auditor certification
• 2-4 years of quality assurance engineering experience in a medical device manufacturing environment

• Working knowledge of FDA 21 CFR Part 820 Quality System Regulation (QSR) - this is essential
• Strong communication skills with the ability to interact effectively with both shop floor personnel and senior leadership
• Computer proficiency in Microsoft Office suite and experience with database systems
• Ability to work in a manufacturing environment (noise, fumes, particulates from plastics processes)
• Ability to lift and carry items up to 50 pounds

Preferred Requirements

• SAP proficiency
• Experience with vendor/customer quality management
• Background in sterilization validation oversight
• Experience conducting complaint investigations with root cause analysis
• Familiarity with statistical methods and quality data analysis

Compensation & Benefits

Salary Range: $90,000 - $100,000

Benefits Package Includes:

• Comprehensive health benefits
• 401(k) retirement plan
• Paid leave days
• Relocation assistance available

Equal Employment Opportunity and Non-Discrimination Policy

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Note: This job posting may be for a position with Keller Executive Search or one of our clients. The specific employer will be identified during the application and interview process. Employment laws and requirements may vary depending on the employer and location.