Quality Assurance Specialist at iHealth Labs Inc

Sunnyvale, California, United States -

Full Time

Start Date

Immediate

Expiry Date

30 Jun, 26

Salary

85000.0

Posted On

01 Apr, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Complaint Handling, Medical Device Reporting, Root Cause Analysis, Corrective Action Planning, Quality Management System, Regulatory Reporting, Audit Support, Cross-Functional Collaboration, Problem-Solving, Analytical Skills, Attention to Detail, Organizational Skills, Multitasking, Bilingual

Industry

Retail Health and Personal Care Products

Description

Work Location: Sunnyvale, CA Pay Range: $71,000 - $85,000 Job Type: Full-Time Onsite OUR COMPANY: Founded in 2010, iHealth Labs is dedicated to empowering people to live healthier lives. The company is a leading provider of cloud-connected medical devices, personal health care devices, and home-based tests, and is at the forefront of the digital health revolution. In November 2021, iHealth's COVID-19 Antigen Rapid Test received Emergency Use Authorization from the U.S. Food and Drug Administration for over-the-counter sales. Since then, iHealth has become a key supplier of at-home COVID tests to the federal government, state governments, nonprofits, and individual consumers. iHealth Labs is a leader in digital health solutions, with a mission to revolutionize the healthcare industry by making quality health management accessible and affordable for all. KEY RESPONSIBILITIES: * Complaint Handling & Reportability * Serve as primary lead for intake, evaluation, and triage of customer complaints. * Assess complaints for Medical Device Reporting (MDR) requirements and determine whether further investigation is needed. * Report confirmed MDRs to the FDA and escalate possible reportable complaints to Original Equipment Manufacturers (OEMs) as appropriate. * Maintain comprehensive complaint documentation and ensure timely resolution and closure. * CAPA: * Lead and manage assigned CAPA investigations, including root cause analysis, corrective action planning, and effectiveness checks. * Support other team members in the execution of additional CAPA activities. * Quality Management System Support: * Assist in the development, implementation, and maintenance of QMS processes in alignment with company standards and regulatory requirements. * Contribute to the creation and improvement of work instructions, forms, process checklists, and nonconformance documentation. * Support the QA team in initiating and assessing Nonconforming Material Reports (NCMRs). * Regulatory Reporting: * Coordinate and manage the timely submission of reportable events to the FDA. * Liaise with OEMs regarding potential MDRs requiring manufacturer evaluation or follow-up. * Audit Support: * Participate in internal and external audits, including preparation, execution, and follow-up activities. * Ensure audit readiness of records and provide documentation or clarification as needed. * Cross-functional Collaboration: * Work closely with QA, Customer Service, Engineering, and other relevant departments to ensure quality standards and processes are upheld. * Other Duties * Perform additional quality-related tasks as assigned by Management in alignment with departmental objectives. QUALIFICATIONS: * Bachelor's degree in a Healthcare, Science, or related technology. * 2+ years of quality assurance experience within the medical device sector. * Hands-on experience performing quality checks on the Healthcare workflow and performance. * Hands-on experience performing quality checks on Healthcare workflow and performance. * Excellent problem-solving and analytical skills. * Attention to detail, excellent organizational skills, and the ability to multitask. * Excellent problem-solving and analytical skills. * Bilingual in Mandarin is a plus. BENEFITS: * Medical, Dental, Vision, Life Insurance, and 401K * Paid Time Off, Federal Holidays, and Leaves * Annual Performance-Based Bonus

Responsibilities

The Quality Assurance Specialist will handle customer complaints, assess them for Medical Device Reporting requirements, and manage CAPA investigations. They will also support the development and maintenance of quality management systems and participate in audits.