Medical Device Quality Engineering Professional #1508

Overview

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 opportunity supports development and enhancement of 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 offers advancement opportunities and the ability to influence regulatory compliance and quality infrastructure.

Responsibilities

• Manage CAPA (Corrective and Preventive Action) processes, including investigating customer complaints, performing root cause analysis, and verifying the effectiveness of corrective actions
• 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 maintenance 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
• Provide quality engineering assistance to manufacturing operations, including developing product specifications, ongoing evaluation, and data analysis to verify products fulfill their intended purpose

Qualifications

Benefits

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

Equal Employment Opportunity

Keller Executive Search and our clients are Equal Opportunity Employers. Qualified applicants will receive consideration for employment without regard to protected status, including race, color, religion, sex, national origin, age, disability, veteran status, or any other legally protected status.

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