Job Requirements

Position Title : Quality Engineer

Department : Quality Assurance and Regulatory

Work Location : Sunnyvale

Annual Pay Range : 80K – 100K

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 2018, iHealth launched its Unified Care program to address the issue of managing chronic diseases. Unified Care specialists support patients at home between doctor’s appointments with remote patient monitoring (RPM) and chronic care management (CCM) to achieve better health outcomes.

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.

Responsibilities

Quality Assurance Processes:

• Develop, implement, and maintain quality assurance procedures and processes in compliance with relevant industry regulations and standards (e.g., FDA, ISO 13485).
• Establish quality control measures, including inspection techniques, sampling procedures, and testing protocols.
• Participate in internal and external audits, including regulatory inspections, and ensure timely resolution of any findings.
• Support risk management activities, including the identification and mitigation of potential quality risks.
  
  

Corrective And Preventive Actions (CAPA)

• Lead investigations into quality issues, customer complaints, and non-conformities to identify root causes.
• Develop and implement effective CAPAs to address identified issues, ensuring timely completion and verification of effectiveness.
• Monitor and track CAPAs to ensure appropriate follow-up and closure.
  
  

Post-Market Surveillance

• Participate in post-market surveillance activities, including complaint handling, adverse event reporting, and product recalls.
• Assist the Complaint Specialist to analyze post-market data and trends to identify opportunities for product and process improvements.
• Collaborate with cross-functional teams to implement necessary actions based on post-market surveillance findings.
  
  

Qualifications And Requirements

• Bachelor’s degree in an engineering discipline; advanced degree preferred.
• 5+ years of experience in quality assurance or quality engineering, with a focus on medical device development and registration.
• Experience in conducting non-conforming material reports (NCMRs), root cause analysis, risk assessments, and implementing corrective and preventive actions (CAPAs).
• Familiarity with design control principles and experience in participating in design reviews.
• Working knowledge of US and international medical device regulations, including FDA 510(k), EUA, and CE marking processes.
• Strong experience with quality management systems (QMS) and compliance with ISO 13485 and FDA Quality System Regulation (QSR).
• Excellent communication and interpersonal skills, with the ability to influence cross-functional teams and external partners.
• Bilingual (English/Chinese Mandarin) is preferred (not required) to support diverse workforce communication.
• Ability to work independently and collaboratively in a multidisciplinary environment.
• Willingness to travel as required for business needs.