Quality Assurance Manager
MMT•Chattanooga, TN
•Onsite
About The Position
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.
Requirements
- Bachelor’s degree in a related field preferred
- 5+ years of experience in manufacturing quality or quality engineering
- Experience in medical device quality assurance strongly preferred
- 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
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
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
Upload and Match Resume
What This Job Offers
Job Type
Full-time
Career Level
Manager
