Quality Assurance Specialist
About The Position
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.
Requirements
- 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.
- Excellent problem-solving and analytical skills.
- Attention to detail, excellent organizational skills, and the ability to multitask.
- Excellent problem-solving and analytical skills.
Nice To Haves
- Bilingual in Mandarin is a plus.
Responsibilities
- 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.
- 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.
- 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).
- Coordinate and manage the timely submission of reportable events to the FDA.
- Liaise with OEMs regarding potential MDRs requiring manufacturer evaluation or follow-up.
- 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.
- Work closely with QA, Customer Service, Engineering, and other relevant departments to ensure quality standards and processes are upheld.
- Perform additional quality-related tasks as assigned by Management in alignment with departmental objectives.
Benefits
- Medical, Dental, Vision, Life Insurance, and 401K
- Paid Time Off, Federal Holidays, and Leaves
- Annual Performance-Based Bonus
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
11-50 employees
