Simon Huang
Strategic Quality Assurance Leader with 11+ years driving ISO 13485 compliance, operational and manufacturing quality leadership across global MedTech networks, accelerating regulatory success and market readiness.
- Role
- Quality Manager at Resonetics
- Location
- Nashua, NH, US
- LinkedIn followers
- 500 followers
About Simon Huang
Decisive analytical leader with 10+ years of experience in ensuring the quality of…
Experience
Quality Manager
Dec 2024 — Present · Nashua, NH, US
Lead the site Quality Engineering team, ensuring timely closures of NCMRs, CAPAs, customer complaints, deviations, and validation activities.• Own Quality Management System (QMS) oversight, including establishing, implementing, and maintaining systems that align with global regulatory requirements such as ISO 13485, FDA QSR, and customer-specific expectations.• Provide strategic leadership by aligning quality initiatives with corporate business goals, identifying opportunities for system optimization, and embedding risk-based thinking across quality functions.• Act as Site Quality Lead and point of contact for regulatory, customer, and internal audits. Serve as both lead auditee and internal auditor, ensuring successful outcomes and implementing corrective actions that strengthen compliance posture.• Directed a successful multi-phased rollout of an enterprise eQMS platform (ETQ), overseeing project planning, cross-site harmonization, and various workflows user training.• Implement risk management practices across the product lifecycle, including supplier controls, process validations, and CAPA investigations, to proactively mitigate regulatory and operational risks.• Drive continuous improvement through data-driven reviews of quality metrics, and management review inputs.• Collaborate cross-functionally with R&D, manufacturing, operations, and supply chain teams to embed quality in design transfer, production, and distribution processes.• Lead and mentor quality teams, locally and across the network, including developing underperforming team members into high-functioning contributors. Deliver training on QMS compliance, regulatory updates, and quality best practices to cross-functional teams.• Track, analyze, and report on key quality and regulatory performance indicators to senior leadership during Management Reviews, ensuring accountability and continuous progress toward quality goals.
Education
Isenberg School of Management, UMass Amherst
Master of Business Administration - MBA
2024 — 2027
University of New Hampshire
BS, Chemical Engineering
2006 — 2011
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