Arya Monticino-Larsen
Ra Qa Engineer @TeDan Surgical Innovations
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WORK HISTORY
Ra Qa Engineer @TeDan Surgical Innovations
Sugar Land, TX, US
Serves as core team member of RA/QA for project development lifecycle. Supports safety, performance, effectiveness and regulatory compliance of TSI products across applicable global markets, including but not limited to compliance with ISO 13485, 21 CFR 820, MDR 2017/745, and MDSAP. Develops and maintain product registrations worldwide. Acts as primary RA/QA contact for OEM customers, providing regulatory documentation and justifications, change notification and assessment, and audit support. Assists with resolution of product and process defects.
EDUCATION
Texas A&M University
Bachelor of Science (B.S.), Mechanical Engineering
Tulane University
Master of Science - MS, Materials Science & Engineering
University of Washington
Pre-Engineering
SKILLS
ABOUT ARYA MONTICINO-LARSEN
Enthusiastic and thoughtful quality and regulatory engineer with a diverse skillset in the medical device industry. I leverage a strong technical background with my degrees in mechanical engineering and materials science, which has served me in environments from early-stage startups to manufacturing plants of top industry players. My strengths lie in applying my technical acumen and thorough understanding of regulations to real-life, unique situations. I understand the challenges of maintaining quality in fast-paced, high-pressure environments, and have demonstrated success in working with cross-functional teams to cultivate a strong quality culture. Above all, I’m passionate about bringing novel, impactful medical devices to market, with safety and efficacy at the forefront.
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