Quality Assurance Manager

1 week ago

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

Location: Sunnyvale, California

Salary Range: $85,000 - $140,000

Employment Type: Full-Time Onsite

About iHealth Labs Inc:

Established in 2010, iHealth is committed to enhancing the health and wellness of individuals. As a pioneer in the design and production of user-friendly, mobile personal healthcare devices integrated with cloud technology, we enable users to effortlessly monitor, track, and share critical health data with healthcare professionals. Our mission is to provide high-quality, accessible products that lead the digital health transformation.

In 2018, we launched the Unified Care initiative to tackle chronic disease management. Our iHealth Care specialists extend support to patients with chronic conditions beyond traditional medical settings through Chronic Care Management (CCM) and Remote Patient Monitoring (RPM), striving for improved health outcomes.

In November 2021, our COVID-19 Antigen Rapid Test received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for over-the-counter distribution. Since then, iHealth has become a significant provider of at-home COVID tests to various entities, including government agencies and individual consumers. Our dedication to fostering healthier lives positions iHealth as a leader in the healthcare sector.

Key Responsibilities:
  • Participate in the quality team to develop, maintain, and revise quality management system documentation and document control.
  • Monitor and assess the implementation of the quality system, making enhancements to ensure its ongoing suitability, adequacy, and effectiveness, while adhering to FDA regulatory standards.
  • Conduct internal and external quality audits, organize internal assessments and management reviews, and ensure follow-up on corrective and preventive actions related to non-conformities.
  • Assist with product risk management, quality assurance, customer feedback, calibration, control of non-conforming products, CAPA, medical device reporting (MDR), and change control processes.
  • Facilitate training for staff on quality management system regulatory requirements.
  • Engage and communicate with local regulatory bodies, manufacturers, and colleagues on quality system matters.
  • Perform additional Quality and Regulatory tasks as assigned.
Qualifications:
  • Bachelor's degree or higher in Pharmaceutical, Biological, Electronic disciplines, a medical field, or equivalent educational background with a focus on self-driven learning and problem-solving.
  • A minimum of 5 years of experience in managing medical device quality systems, with familiarity in medical device regulatory requirements in the USA and Canada (e.g., ISO13485, 21CFR 820), demonstrating a thorough understanding of quality management system frameworks.
  • Proven ability to manage small projects, showcasing exceptional organizational skills, independence, and a results-oriented mindset.
  • Excellent analytical and communication abilities, complemented by a strong sense of teamwork and meticulous attention to detail.
  • Fluency in both English and Mandarin, facilitating effective communication within a diverse team and potential global partners.
Benefits:
  • Comprehensive Medical, Dental, Vision, Life Insurance, and 401K plans.
  • Generous Paid Time Off, Federal Holidays, and Leave policies.
  • Annual Performance-Based Bonus.
Equal Opportunity Statement

iHealth Labs is dedicated to fostering diversity within its workforce and proudly stands as 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 category. iHealth Labs is an Affirmative Action and Equal Opportunity Employer.

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