Quality Manager

Cordica Medical is a mission‑driven medical device company dedicated to advancing patient care through thoughtful innovation and clinical excellence. We specialize in developing and commercializing technologies that address meaningful unmet needs, with a focus on improving outcomes, efficiency, and quality of life for patients and providers alike.

Our team brings together experienced professionals from clinical, engineering, regulatory, and operational backgrounds who share a commitment to integrity, collaboration, and impact. At Cordica Medical, every role contributes directly to our purpose—translating smart ideas into practical solutions that make a real difference in healthcare.

If you’re looking to grow your career in an environment that values accountability, curiosity, and teamwork, Cordica Medical offers the opportunity to do meaningful work while helping shape the future of medical technology.

Cordica Medical, Morristown TN is seeking a Quality Manager to join our Woodstock, Georgia team. This position is responsible for the development, implementation, and maintenance of the Quality Management System in compliance with ISO 13485, FDA 21 CFR Part 820, EU MDR, and ISO 14971 risk management requirements. Lead all quality assurance activities, serve as Management Representative with organizational freedom and authority to resolve quality matters, ensure regulatory compliance, manage CAPA programs, and oversee risk management integration throughout the organization.

• Serve as Management Representative per FDA 21 CFR 820.20(b)(3) and ISO 13485:2016 Clause 5.5.2 with organizational freedom and authority independent of other responsibilities to ensure QMS requirements are established, implemented, and maintained; resolve quality matters; and report to top management on QMS performance and improvement needs
• Serve as designated authority for risk management system oversight per ISO 14971:2019 Clause 4.2, ensuring the risk management process is established, maintained, and periodically reviewed for continued suitability
• Own regulatory reporting process including MDR (21 CFR Part 803), EU vigilance, and adverse event notifications; establish procedures for timely reporting to FDA, notified bodies, and international regulatory authorities (ISO 13485: 8.2.3, 21 CFR 820.198(d))
• Develop, implement, and maintain the Quality Management System per ISO 13485:2016 and 21 CFR Part 820 requirements
• Lead internal audit program planning, execution, and follow-up per ISO 13485 Clause 8.2.4 and 21 CFR 820.22
• Coordinate and lead management review meetings; prepare inputs and document outputs (ISO 13485: 5.6, 21 CFR 820.20(c))
• Own the CAPA system including root cause analysis, corrective action verification, and effectiveness monitoring (ISO 13485: 8.5, 21 CFR 820.100)
• Manage complaint handling program including intake, investigation, trending, and regulatory reporting evaluation (21 CFR 820.198)
• Own internal communication processes to disseminate quality information, CAPA results, policy changes, and regulatory awareness throughout the organization (ISO 13485: 5.5.3, 21 CFR 820.100(a)(6))
• Own validation of software used in QMS, production monitoring, and quality system automation per 21 CFR 820.70(i) and ISO 13485 Clause 4.1.6; maintain validation records
• Establish and maintain procedures for identifying valid statistical techniques required for process capability, acceptance sampling, trend analysis, and data-driven decision making (ISO 13485: 8.4, 21 CFR 820.250)
• Own the documented feedback collection procedure for gathering and analyzing production and post-production information (ISO 13485: 8.2.1)
• Own the traceability system ensuring device unit, lot, or batch can be traced through distribution; define traceability extent based on regulatory requirements (ISO 13485: 7.5.8, 21 CFR 820.65)
• Oversee validation of contract manufacturer processes; approve validation protocols; verify validation status during supplier audits (ISO 13485: 7.5.6, 21 CFR 820.75)
• Establish process for reviewing post-production information (complaints, service data, literature) for risk management relevance; coordinate updates to risk management…