Quality Assurance Manager

7 days ago


Sunnyvale, California, United States Ihealth Labs Inc Full time
Job Summary

We are seeking a highly skilled Quality Assurance Manager to join our team at iHealth Labs Inc. As a key member of our quality team, you will be responsible for establishing, maintaining, and revising our quality management system documents and document control.

Key Responsibilities
  • Monitor and evaluate the implementation of our quality system, making improvements to ensure the continued suitability, adequacy, and effectiveness of our quality management system, and compliance with FDA regulatory requirements.
  • Responsible for internal and external quality audits, organizing internal audits and management review, and following up on corrective and preventive actions taken to non-conformities.
  • Support matters related to product risk, quality, customer complaints, calibration, control of non-conforming products, CAPA, medical device reporting (MDR), and change control.
  • Responsible for the training of company staff on quality management system regulatory requirements.
  • Responsible for interacting and communicating with local regulatory authorities, manufacturers, and colleagues in China on matters related to the quality system.
  • Other quality and regulatory duties as assigned.
Requirements
  • Bachelor's degree or above in Pharmaceutical, biological, electronic professional, a medical field, or an equivalent educational background with a focus on self-motivated learning and problem-solving.
  • A minimum of 5 years of experience in medical device quality system management, familiar with medical device regulatory requirements in USA and Canada (e.g. ISO13485, 21CFR 820), showcasing a comprehensive understanding of quality management system frameworks.
  • Demonstrated ability to manage small projects, displaying exceptional organization, independence, and outcome-driven focus.
  • Outstanding analytical and communication skills, paired with a strong sense of teamwork and meticulous attention to detail.
  • Fluent in both English and Mandarin, enabling effective communication within a diverse team and potential global partners.
Benefits
  • Medical, Dental, Vision, Life Insurance, and 401K
  • Paid Time Off, Federal Holidays, and Leaves
  • Annual Performance-Based Bonus

iHealth Labs Inc is committed to diversity in its workforce and is proud to be an equal opportunity employer. We consider qualified applicants without regard to race, color, religion, creed, gender, national origin, age, disability, veteran status, marital status, pregnancy, sex, gender expression or identity, sexual orientation, citizenship, or any other legally protected class.



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