(Senior) Quality Manager
Job DescriptionJob DescriptionWork Location: Sunnyvale, California
Salary Range: $85,000 - $140,000
Job Type: Full-Time Onsite
Our Company:
Founded in 2010, iHealth is dedicated to empowering people to live healthier lives. The company is a leader in designing and manufacturing consumer-friendly, mobile personal healthcare products connected through the cloud that allows consumers to easily measure, track, and share vital health information with their doctors. With a focus on delivering high-quality and accessible products, iHealth is at the forefront of the digital health revolution.
In November 2021, iHealth's COVID-19 Antigen Rapid Test received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for over-the-counter sales. Since then, iHealth has emerged as a key supplier of at-home COVID tests to the federal government, state governments, nonprofits, and individual consumers. With its commitment to helping people lead healthier lives, iHealth is poised to continue driving positive change in the healthcare industry.
Job Responsibilities:
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In this role, you will be part of the quality team responsible for establishing, maintaining, and revision of quality management system documents and document control.
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Leads and manages a quality assurance team in the U.S. Plans resource requirements for projects.
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Responsible for monitoring and evaluating the implementation of the quality system, making improvements to ensure the continued suitability, adequacy, and effectiveness of quality management system (QMS), and complying with FDA and ISO 13485 quality system regulations and requirements.
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Responsible for internal and external quality audits, organizing/conducting internal audits and management reviews, hosting external audits, and following up on audit findings and management review actions including corrective and preventive actions.
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Support matters related to product risk, quality, customer complaints, calibration, control of non-conforming products, CAPA, medical device reporting (MDR), and change control.
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Responsible for the training of company staff on quality management system requirements.
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Responsible for establishing new or revised processes/procedures to meet new/changing regulatory requirements.
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Responsible for verification and validation of computer systems used in managing QMS related activities.
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Responsible for interacting and communicating with local regulatory authorities, auditing bodies, manufacturers in the U.S. and colleagues in China on matters related to the quality system. Fosters an inclusive environment where continuous improvement and innovation ideas are implemented.
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Other Quality and Regulatory duties as assigned.
Qualifications:
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Bachelor’s degree or above in Life Sciences, engineering, a medical field, or an equivalent educational background with a focus on self-motivated learning and problem-solving.
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A minimum of 5 years of hands-on experience in medical device quality system management, familiar with USA 21 CFR 820 and ISO13485, showcasing a comprehensive understanding of quality management system requirements and successful implementation and maintenance of effective Quality Management System.
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Demonstrated ability to manage cross-functional projects, displaying exceptional organization, independence, and outcome-driven focus.
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Outstanding analytical and written and verbal communication skills, paired with a strong sense of teamwork and meticulous attention to detail.
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Proactive approach and strong critical thinking skills.
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Strong collaboration, relationship management and interpersonal skills.
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Minimum 2 years of managerial experience in the medical device industry.
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Demonstrated managerial skills in hiring, and developing talents.
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Fluent in both English and Mandarin, enabling effective communication within a diverse team and potential global partners.
Benefits:
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Medical, Dental, Vision, Life Insurance, and 401K
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Paid Time Off, Federal Holidays, and Leaves
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Annual Performance-Based Bonus