Quality Assurance Manager

Location: Chattanooga, Tennessee Industry: Manufacturing At Medical Manufacturing Technologies (MMT), we are focused on developing excellence in automation, machine design, material handling, and custom tooling. Every role plays a part in our success through accountability, responsiveness, and a practical, solutions-focused approach. We are seeking a Quality Assurance Manager to lead and maintain our Quality Management System (QMS) in alignment with ISO 13485:2016, customer requirements, and regulatory standards. This role is critical in driving quality performance, supporting compliance, and partnering across teams to ensure consistent execution. Key Responsibilities Develop, implement, and maintain quality systems, policies, and procedures in compliance with ISO 13485 Lead and manage CAPA processes, including investigations, root cause analysis, and timely closure Oversee nonconformances, deviations, RMAs, and supplier corrective actions (SCARs) Conduct and support customer complaint investigations, including technical communication with customers Manage document and record control processes Develop and maintain internal audit schedules and coordinate external audits (ISO registrar, customer, supplier) Compile and present data for Management Review Partner with Purchasing to define and monitor supplier quality requirements Track, analyze, and report quality metrics to leadership Drive continuous improvement initiatives and promote a strong quality culture Ensure customer requirements are integrated into processes and documentation Provide guidance to leadership on QMS performance Qualifications Education: Bachelor’s degree in a related field preferred. Experience: 5+ years of experience in manufacturing quality or quality engineering Experience in medical device quality assurance strongly preferred Skills & Knowledge: Working knowledge of ISO 13485 or ISO 9001 Familiarity with FDA CFR 820, EU MDR, REACH, RoHS, Prop 65, or similar regulations preferred Experience with polymer extrusion or injection molding is a plus Strong understanding of quality management tools and methodologies Ability to interpret technical drawings and customer requirements Strong problem-solving and critical thinking skills Proven leadership and organizational skills Hands-on, team-oriented approach with strong interpersonal skills Proficiency in Microsoft Office; ERP experience preferred ASQ certifications and Six Sigma (Yellow/Green/Black Belt) strongly preferred Medical Manufacturing Technologies (MMT) is an equal opportunity employer. We are committed to creating an inclusive environment for all employees and applicants. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic under applicable law. MMT is committed to providing reasonable accommodations to qualified individuals with disabilities. If you need assistance or accommodation during the application or interview process, please contact us. MMT participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the United States. #J-18808-Ljbffr Page Mechanical Group, Inc.