PRIMARY OBJECTIVES AND RESPONSIBILITIES
- Lead daily quality operations at the manufacturing site, including incoming, in-process, and final inspection, testing, and product release.
- Oversee Quality Management System (QMS) processes such as change control (ECR/ECO), document management, records retention, training/competency, CAPA, NCMR, complaints, and calibration.
- Supervise and develop Quality Engineers and Quality Assurance personnel, including performance management, coaching, and workforce planning.
- Ensure compliance with FDA QMSR, ISO 13485, MDSAP, and Good Documentation Practices through effective procedures and controls.
- Lead internal and external audits, including ISO/MDSAP audits and regulatory inspections, serving as the site's primary host.
- Maintain and monitor quality metrics and KPIs, presenting monthly results and driving actions through Management Review and other Quality governance processes.
- Lead investigations for quality trends and issues, implementing corrective and preventive actions to improve outcomes.




- Support risk management processes and ensure integration into key quality activities, including complaints, nonconformances, and change control.
- Bachelor’s degree in engineering, quality, or related scientific field (or equivalent experience).
- Minimum 5 - 8 years of working experience in Quality within a regulated manufacturing environment, or advanced degree with 3 years of relevant experience.
- 3 plus years leading Quality Operations in a medical device manufacturing site along with Quality projects.
- Strong knowledge and working experience with ISO 13485, MDSAP, FDA QMSR (21 CFR Part 820) requirements, and Good Documentation Practices.
- Experience maintaining and improving an effective Quality Management System.
- Experience managing quality assurance and regulatory compliance to drive audit and inspection readiness.
- Experience guiding and coaching others.
- Experience with FDA inspections and registrar/notified body a

📌 Quality Manager (Baja California)
🏢 Mam De La Frontera, S. A. De C. V.
📍 Baja California