- Develop, implement, and maintain a robust and compliant quality management system in accordance with FDA regulations (21 CFR Part 820) and ISO 13485 standards.
- Monitor and enforce adherence to quality policies, procedures, and work instructions across all manufacturing processes.
- Stay current with FDA regulations and international medical device regulations to ensure the company's practices align with industry requirements.
- Collaborate with regulatory affairs to prepare and submit regulatory documentation, including 510(k) submissions and other regulatory filings.
- Ensure that manufactured medical devices meet or exceed quality standards, specifications, and performance requirements.
- Implement robust inspection and testing processes to detect and prevent defects, deviations, and non-conformities.
- Lead risk management activities for the production, identifying potential risks associated with manufacturing processes and products.
- Develop and execute risk mitigation strategies to minimize product-related risks.
- Collaborate with the procurement team to assess and qualify suppliers based on quality and regulatory criteria.
- Establish and maintain supplier quality agreements, conduct audits, and manage supplier corrective actions.
- Plan and coordinate internal audits to assess the effectiveness of the QMS and manufacturing processes.
- Participate in audits and inspections by regulatory authorities, addressing findings and implementing corrective and preventive actions (CAPAs).
- Drive a culture of continuous improvement by identifying process inefficiencies and opportunities for optimization.
- Lead cross-functional teams to implement process enhancements and ensure sustained quality improvement.
- Oversee the creation, review, and revision of manufacturing and quality-related documents, ensuring accuracy and compliance.
- Maintain an organized and up-to-date document control system.
- Ensure accurate and comprehensive documentation of quality process, procedures, and production records.
- Provide training and guidance to manufacturing personnel on quality procedures, regulations, and best practices.
- Foster a sense of ownership for quality among all employees.
- Develop and present quality metrics and performance reports to senior management, highlighting key trends, achievements, and areas for improvement.
- Bachelor's degree in engineering, life sciences, or a related field; advanced degree preferred.
- Significant experience (typically 5+ years) in quality assurance within medical device manufacturing, with a strong understanding of FDA regulations and ISO 13485 standards.
- Proven experience in leading quality improvement initiatives and managing cross-functional teams.
- Proficiency in risk management methodologies and root cause analysis techniques.
- Experience with internal and external audits, regulatory inspections, and interactions with regulatory agencies.
- Detail-oriented mindset with a commitment to maintaining accurate records and documentation.
- Proficiency in using quality management software and tools.
- Strong communication, leadership, and team-building skills.
- Excellent problem-solving skills and the ability to make sound decisions under pressure.
- Quality management certification (e.g., CQM, CMQ/OE) preferred.
- Bilingual in English / Chinese is a must.
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Manufacturing_Quality Assurance Manager - Baldwin Park, United States - Ihealth Labs Inc
Description
Job Description
Job DescriptionCompany DescriptioniHealth is dedicated to empowering healthier lives. As a pioneer of digital health from Silicon Valley, iHealth was founded in 2010 and launched the world's first Bluetooth-connected blood pressure monitor that worked with iOS devices. Through more than a decade of development, by integrating its FDA-approved, award-winning consumer medical devices and remote patient monitoring platform, iHealth has established a digital health ecosystem, the Unified Care model, for healthcare providers to manage chronic diseases remotely. To date, iHealth is one of the top brands in digital health & wellness and has expanded its Unified Care model to 13 states with significant clinical outcomes in hypertension and diabetes management.
During the first year of the COVID-19 pandemic, iHealth was actively supporting the fight against COVID-19 by being one of the leading manufacturers of thermometers, shipping millions of them to its customers. On November 5th, 2021, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for over-the-counter (OTC) sale of iHealth's COVID-19 Antigen Rapid Test. iHealth has since been a major supplier of at-home tests to the federal government, state governments, nonprofit organizations, and individuals.
Work Location: Irwindale, CA 91706
Position Overview:
The Quality Assurance Manager of iHealth Manufacturing is responsible for leading and overseeing the quality assurance activities within the company's medical device manufacturing operations. This role involves ensuring compliance with regulatory standards, maintaining product quality, and driving continuous improvement initiatives to enhance manufacturing processes.
Responsibilities:
Quality Management System (QMS)
Regulatory Compliance
Product Quality Assurance
Risk Management
Supplier Quality Management
Internal and External Audits
Continuous Improvement
Document Control
Training and Development
Metrics and Reporting
Qualifications:
