Medical Device Quality Engineering Professional #1508

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.

Key Responsibilities

• 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