Lexington Medical designs and manufactures AEON™ surgical stapling technology at our Bedford, MA headquarters. We seek a Senior Quality Systems Specialist to own the eQMS (Arena) and keep it compliant with ISO 13485, FDA QMSR, 21 CFR Part 11, MDSAP, and EU MDR, driving CAPA, change control, supplier quality, and quality metrics.
You will partner with Operations, Engineering, Regulatory, and Manufacturing to maintain audit readiness for certifications and regulatory inspections in a fast-paced
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Senior Quality Systems Lead — eQMS & Compliance in Bedford employer: Lexington Medical, Inc.
At Lexington Medical, Inc., we pride ourselves on being an exceptional employer in the heart of Bedford, Massachusetts, where innovation meets a collaborative work culture. Our commitment to employee growth is evident through hands-on opportunities and a supportive environment that encourages creativity and technical curiosity, allowing you to make a meaningful impact in the MedTech industry while working alongside passionate professionals dedicated to improving patient outcomes.
