Quality Assurance Manager

Company Description

Founded in 2015 and headquartered in Shenzhen, SiBionics is one of the world's fastest

growing innovators in continuous glucose monitoring (CGM) and digital health solutions.

Our flagship GS1 and GS3 CGM systems are CE-marked under MDR and approved in China,

making SiBionics the world's top 3 CGM provider by user base. With a global team of more

than 500 employees, we are dedicated to transforming chronic disease management

through accessible, reliable, and user-friendly medical devices.

Our goal is to bring the latest medical technology into the hands of the end user, making it

easier for people to manage their own health. The QA Manager helps to achieve this goal

by building and maintaining a robust Quality Management System (QMS) that ensures our

products meet the highest standards of safety, effectiveness, and compliance throughout

their lifecycle.

Role Description

Lead the development, implementation, and maintenance of an FDA-compliant QMS

(21 CFR Part 820, ISO 13485, ISO aligned with product development and

future commercialization plans.

Oversee design control, risk management, and document control processes to ensure

product development activities meet FDA requirements.

Collaborate with R&D, Regulatory Affairs, Clinical Affairs, and Manufacturing teams to

ensure quality deliverables for U.S. clinical and regulatory submissions.

Identify potential risks and implement mitigation strategies to prevent quality-related

issues.

Establish frameworks for core quality processes such as supplier quality

management, CAPA, nonconformance handling, change control, post-market

surveillance and complaint handling as products progress to commercialization.

Lead internal audits and readiness for FDA inspections and external audits.

Provide quality training and raise compliance awareness across the organization.

Other duties as needed.

Qualifications

Bachelor's degree in Engineering, Life Sciences, or related field (Master's degree

preferred).

5+ years of Quality Assurance experience in a GxP-regulated environment

(biotechnology, or medical device industry), preferably with Class II or Class III

devices.
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Demonstrated knowledge of FDA QSR (21 CFR Part 820), ISO 13485, ISO 14971 and

hands-on experience in QMS implementation.

Experience working with wearable, software-enabled, or diagnostic devices

Bilingual (English and Mandarin)

CQE, CQA, or RAC certification