Medical Device Quality Engineering Professional

Our client, a well-established producer of plastic medical devices, is looking for a Quality Engineering Professional to join their facility in Galloway, Tennessee. This presents an outstanding opportunity to develop and enhance essential quality operations within an FDA-regulated production setting.

The organization produces Class I and II medical device solutions including sterile packaging, patient care products, and biohazard containment items utilizing bag manufacturing and plastic injection molding technologies. Supported by a robust parent organization and operating across several locations, this position provides authentic advancement opportunities and the ability to significantly influence regulatory compliance and quality infrastructure.

• Manage CAPA (Corrective and Preventive Action) processes, including investigating customer complaints, performing root cause analysis, and verifying effectiveness of corrective measures
• Supervise and guide Quality Assurance Auditors and Analysts in their daily quality assurance responsibilities
• Support ongoing improvement programs throughout production operations
• Facilitate the creation and upkeep of a robust Quality Management System (QMS) aligned with ISO 13485:2016 standards and FDA 21 CFR Part 820 (QSR) for Class I and II medical devices
• Act as the quality point of contact with vendors and customers regarding quality issues
• Conduct training sessions for cross-functional teams covering regulatory requirements, quality science, and statistical techniques
• Monitor sterilization validation and regulatory adherence for medical device products sterilized by contract facilities
• Direct and participate in external and internal quality audits, maintaining preparedness for regulatory inspections from FDA, Health Canada, and additional regulatory bodies
• Maintain compliance with applicable regulatory requirements including AAMI sterilization standards, FDA, Health Canada, EPA, OSHA, and others
• Deliver quality engineering assistance to manufacturing operations, including developing product specifications, ongoing evaluation, and analyzing data to verify products fulfill their intended purpose

• Working knowledge of FDA 21 CFR Part 820 Quality System Regulation (QSR) - this is critical
• Bachelor's degree from an accredited institution in Quality, Mechanical Engineering, or Industrial Engineering
• Capability to lift and carry materials up to 50 pounds
• Proficiency with database systems and Microsoft Office suite
• ISO 13485:2016 Lead Auditor certification
• Ability to function in a manufacturing setting (exposure to particulates from plastics processes, fumes, and noise)
• 2-4 years of experience in quality assurance engineering within a medical device manufacturing setting
• Excellent communication abilities with capacity to engage effectively with senior leadership and shop floor staff
• Background in blow molding and/or plastic injection molding manufacturing operations

• Knowledge of statistical methods and analysis of quality data
• Experience managing vendor/customer quality relationships
• Background overseeing sterilization validation processes
• SAP proficiency
• Experience performing root cause analysis in complaint investigations

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

Equal Employment Opportunity Statement: Both Keller Executive Search and our clients are Equal Opportunity Employers. For all positions, whether with Keller Executive Search or our clients, qualified applicants will receive consideration for employment without regard to race, skin color, religion, sex, sexual orientation, gender identity, gender expression, national origin, age, protected veteran status, disability, genetic information, or any other legally protected status.

Commitment to Diversity: Keller Executive Search and its clients are committed to fostering a diverse and inclusive work environment where all individuals are valued and respected.

Reasonable Accommodations: Both Keller Executive…