Keller Executive Search ยท 1 month ago
Quality Assurance Engineer (Medical Device Manufacture)
Gallaway, Tennessee, United States
Full-time
Onsite
Mid, Senior LevelKeller Executive Search is representing a well-established medical device manufacturer specializing in plastic medical products. They are seeking a Quality Assurance Engineer to build and strengthen a critical quality function within a FDA-regulated manufacturing environment, ensuring compliance with quality standards and regulatory requirements.
Staffing & Recruiting
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
Qualification
Required
Experience in developing and maintaining a Quality Management System (QMS) compliant with FDA 21 CFR Part 820 and ISO 13485:2016 standards for Class I and II medical devices
Experience leading and participating in internal and external quality audits
Experience managing CAPA (Corrective and Preventive Action) systems, including root cause analysis and investigation of customer complaints
Experience overseeing sterilization validation and compliance for contract-sterilized medical device products
Experience providing quality engineering support to production, including product specification development and data analysis
Experience serving as a quality liaison with customers and vendors on quality-related matters
Experience delivering training on statistical techniques, quality science, and regulatory requirements
Experience supervising and directing Quality Assurance Analysts and Auditors in quality assurance activities
Knowledge of compliance with FDA, Health Canada, AAMI sterilization standards, OSHA, EPA, and other applicable regulatory requirements
Experience supporting continuous improvement initiatives across manufacturing operations
Company
Keller Executive Search
Keller Executive Search is a boutique executive recruitment and advisory firm dedicated to connecting top-tier talent with leading organizations worldwide.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase