Quality Manager
Core
Ensures regulatory, quality, and compliance adherence for medical device manufacturing and 3PL logistics operations.
Role type
Senior Quality & Regulatory Compliance Manager
Builds
Quality management systems and compliant medical device supply chain processes
Domain
Healthcare / Medical Devices / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality Management System (QMS) design and maintenance, FDA QSR and cGMP regulatory compliance, ISO 13485 and ISO 9001 standards, risk management, vendor and product quality audit execution, design transfer management, personnel hiring and training, process validation, EHS policy compliance
Preferred skills
DEA and human tissue regulations knowledge, distribution and legislative environment expertise, regulatory action plan development, liaison with regulatory agencies
Technologies
Microsoft Word, Excel, PowerPoint, Outlook
Responsibilities
Develop and maintain the company's Quality system; report to top management on QMS performance; ensure quality documentation is current and controlled; oversee quality testing and product release; conduct internal, vendor, and product quality audits; manage Design Transfer for new products; establish organizational structure for quality conformance; represent the site for FDA and corporate audits; validate processes; coordinate Quality Assurance resources; support EHS policy and compliance
Seniority
Senior, hands-on IC with supervisory responsibilities
