Quality Assurance Manager (Medical Device)

We’re building the U.S. quality organization for a global CGM medical device company and are looking for a hands-on Quality Assurance Manager to lead QMS, design control, and FDA readiness as we scale.

About the Company

Founded in 2015, SiBionics is a global innovator in continuous glucose monitoring (CGM) and digital health solutions. Our GS1 and GS3 CGM systems are CE-marked under MDR and approved in China, supporting a growing global user base.

With a team of over 500 employees worldwide, we are focused on developing accessible, reliable, and user-friendly medical devices that empower people to better manage chronic conditions.

As we continue to expand our U.S. operations, we are building a strong local quality organization to support product development, clinical activities, and future FDA submissions.

About the Role

The Quality Assurance Manager will play a key role in establishing and maintaining a robust, FDA-compliant Quality Management System (QMS) to support U.S. product development and commercialization.

This is a hands-on role suited for someone who enjoys building quality systems, partnering closely with cross-functional teams, and working in a growth-stage medical device environment.

Key Responsibilities

• Lead the development, implementation, and maintenance of an FDA-compliant QMS in accordance with 21 CFR Part 820, ISO 13485, and ISO 14971
• Own and oversee Design Control, Risk Management, and Document Control processes across the product lifecycle
• Collaborate with R&D, Regulatory Affairs, Clinical Affairs, and Manufacturing teams to ensure quality deliverables support U.S. clinical and regulatory submissions
• Identify quality and compliance risks and implement effective mitigation strategies
• Establish and maintain core quality processes, including:
• Supplier Quality Management
• CAPA and Nonconformance Handling
• Change Control
• Complaint Handling and Post-Market Surveillance
• Lead internal audits and support readiness for FDA inspections and external audits
• Develop and deliver quality training to promote compliance awareness across the organization
• Support additional quality initiatives as needed during company growth

Required Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or a related field (Master’s degree preferred)
• 5 years of Quality Assurance experience in a GxP-regulated environment (medical device or biotechnology preferred)
• Hands-on experience implementing and maintaining QMS under FDA QSR (21 CFR Part 820), ISO 13485, and ISO 14971
• Experience supporting Class II or Class III medical devices

Preferred Qualifications

• Experience with wearable, software-enabled, or diagnostic medical devices
• Exposure to early-stage or growth-stage medical device companies
• CQE, CQA, RAC, or related certification
• Bilingual in English and Mandarin
• Entrepreneurial mindset and comfort working in a fast-paced, evolving environment