Noe Marie Rivera
Medical Device Quality Expert | Leading QMS Transformation, Global Compliance & Operational Excellence
- Role
- Senior Director Quality Management Systems at Siemens Healthineers
- Location
- Seattle, WA, US
- LinkedIn followers
- 500 followers
About Noe Marie Rivera
I’m a quality executive with 20+ years driving compliance, operational excellence, and strategic quality leadership in healthcare and life sciences. As Senior Director of Quality Management Systems at Siemens Healthineers, I focus on ISO 13485 compliance, medical device regulations, and building scalable quality systems that enable innovation while safeguarding patient safety.I bring deep expertise in pharmaceuticals and medical devices, leading high-performing teams, solving complex challenges collaboratively, and implementing processes that deliver measurable results. I’m passionate about aligning regulatory compliance with business strategy, elevating organizational quality, and building trust—helping organizations grow sustainably while maintaining the highest standards.
Experience
Senior Director Quality Management Systems
Aug 2024 — Present · Issaquah, WA, US
Global Quality leader managing Siemens Healthineers Ultrasound QMS across five design and manufacturing sites. Spearheaded a major QMS transformation to streamline processes, reduce redundancies, and improve operational efficiency, enabling innovation while ensuring regulatory compliance.Responsible for all regulatory and notified body audits, complaint resolution, risk management, internal audits, and post-market surveillance. KEY CONTRIBUTIONS & ACHIEVEMENTS: Directed global QMS strategy across U.S. and EU manufacturing sites, enabling rapid scale-up of a new EU facility and achieving ISO 13485 & MDSAP certification in under 6 months. Architected FDA-recognized CAPA process redesign, driving double-digit reductions in recurrence, cycle time, and audit observations. Deployed digital eQMS integrating eight enterprise processes, increasing visibility, reducing cycle times, and eliminating legacy system variability.
Education
Seattle University School of Law
Master of Legal Studies in Risk Management & Compliance
Purdue University
Bachelor of Science - BS, Chemistry
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