Medical Device QMS Manager
3 weeks ago
We're seeking an experienced quality professional to lead our regulatory affairs efforts in China. As a Sr. QA Specialist China/HK, you'll play a vital role in maintaining compliance with NMPA regulations and driving quality improvement initiatives within our organization. Your expertise in quality management systems, coupled with your ability to navigate complex regulatory landscapes, will be instrumental in shaping our compliance strategy.
Main Responsibilities:
• Collaborate with cross-functional teams to ensure QMS compliance in China.
• Identify and address gaps in our existing QMS to align with Chinese regulations.
• Stay current on new NMPA regulatory requirements and share insights with stakeholders.
• Assess proposed changes for their regulatory impact and coordinate implementation plans through the change management system.
• Provide expert guidance on manufacturing and engineering processes from a China/HK quality perspective.
Key Requirements:
• Minimum 8+ years of experience in quality systems or a related field, preferably in the medical device industry (China QMS a plus).
• Familiarity with NMPA Decree 739, US FDA requirements (CFR 21 Part 820), and ISO 13485 QMS standards.
• Demonstrated ability to navigate complex quality and compliance systems with minimal oversight.
• Excellent analytical, strategic thinking, and project management skills.
• Prior audit management experience is essential (NMPA audit a plus).
• Excellent written and verbal communication skills are required.
• Excellent negotiation skills and ability to work effectively in cross-functional and multicultural teams.
• Highly proficient in Microsoft Office applications, including Word, Excel, and Project.
• Knowledge of SAP, Agile, or similar business systems is desired.
• Must be willing to travel internationally once company travel is approved.
Estimated Salary:$150,000 per year.
-
Senior Sap Qm Implementation Expert
4 days ago
Sunnyvale, California, United States GForce Life Sciences Full time**Job Title:**Sap Quality Management Consultant**Company Overview:**GForce Life Sciences is a leading provider of innovative solutions to the life sciences industry. We are committed to delivering high-quality services that meet the evolving needs of our clients.**Job Description:**We are seeking a Sap Quality Management Consultant to join our team. In this...
-
Manufacturing Process Expert SAP QM
1 day ago
Sunnyvale, California, United States eTeam Full timeJob Overview">eTeam is seeking an experienced SAP QM analyst to join our team. In this role, you will be responsible for managing the quality management process within our manufacturing operations.">About the Role">Develop and implement quality management processes in accordance with industry standardsAnalyze data to identify trends and areas for...
-
Medical Device Regulatory Manager
6 days ago
Sunnyvale, California, United States IntelliPro Group Inc. Full timeWe are seeking a highly motivated Senior Regulatory Affairs Specialist to join our team at IntelliPro Group Inc.As a key member of our regulatory team, you will be responsible for ensuring the proper oversight of medical device development and market introduction. You will work closely with Quality, Engineering, Product Management, Marketing, and Sales teams...
-
Business Process Optimization Expert
3 weeks ago
Sunnyvale, California, United States GForce Life Sciences Full timeBusiness Process Optimization Expert - SAP QMGForce Life Sciences is committed to delivering high-quality solutions that meet the evolving needs of our customers. To achieve this goal, we are seeking a seasoned Business Process Optimization Expert - SAP QM to join our team.About the Role:We are looking for a highly experienced professional with a minimum of...
-
Senior Technical Lead
3 weeks ago
Sunnyvale, California, United States Intuitive Full timeTechnical Lead - Robotics">As a Senior Technical Lead for Medical Devices, you will be responsible for leading cross-functional teams to develop and commercialize innovative medical devices.">Your expertise in robotics and medical device development will drive the creation of cutting-edge solutions that transform patient care.">About the Role">This technical...
-
Quality Assurance Specialist
4 weeks ago
Sunnyvale, California, United States Intuitive Full timeJob DescriptionWe are seeking a highly skilled Quality Assurance Specialist to join our team in China/Hong Kong. As a key member of our quality team, you will play a pivotal role in ensuring compliance with China's National Medical Products Administration (NMPA) Quality Management System (QMS) requirements.This position supports our strategic priorities in...
-
Sunnyvale, California, United States GForce Life Sciences Full timeJob Title: Regulatory Affairs Specialist IIGForce Life Sciences is seeking a highly skilled Regulatory Affairs Specialist II to join our team.Job Summary:The successful candidate will be responsible for preparing and managing regulatory submissions to USFDA and OUS regulatory authorities, with a focus on medical devices and digital health technologies. The...
-
Medical Device Quality Systems Lead
3 weeks ago
Sunnyvale, California, United States Ihealth Labs Inc Full timeAbout the RoleThe Medical Device Quality Systems Lead will be responsible for establishing, maintaining, and revising quality management system documents and document control.This includes leading and managing a quality assurance team in the U.S., planning resource requirements for projects, and monitoring the implementation of the quality system.The ideal...
-
Medical Device Compliance Specialist
1 day ago
Sunnyvale, California, United States IntelliPro Group Inc. Full timeJob DescriptionAs a key member of our regulatory team, you will be responsible for proper oversight of medical device development and market introduction. You will work closely with Quality, Engineering, Product Management, Marketing, and Sales teams to perform regulatory pre- and post-market analysis, and implement and maintain an ISO 13485 and FDA...
-
Program Manager for Device Development
2 days ago
Sunnyvale, California, United States Amazon Full timeDevice Development Program ManagerManage the development of innovative consumer products from concept to mass production.About the RoleThis position involves leading cross-disciplinary teams in developing groundbreaking devices.Collaborate with stakeholders to define strategies and requirements.Deeply analyze technical issues and guide teams to find...
-
Medical Device Documentation Expert
4 weeks ago
Sunnyvale, California, United States eTeam Full time**About the Role**eTeam is hiring a Medical Device Documentation Expert to join our team. In this role, you will be responsible for creating high-quality documentation for medical devices.• Salary: $90,000 - $120,000 per year**Responsibilities:**• Develop clear and concise instructions for use (IFU) for medical device robotic assisted systems and...
-
Global Quality Compliance Specialist
3 weeks ago
Sunnyvale, California, United States Intuitive Full timeJob OverviewThe Sr. QA Specialist China/HK will play a pivotal role in ensuring Intuitive Surgical, Inc. (ISI) complies with China's National Medical Products Administration (NMPA) Quality Management System (QMS) requirements. This position supports ISI's strategic priorities in China, facilitates communication between ISI and its joint venture (JV) with...
-
Mobile Device Management Automation Specialist
3 weeks ago
Sunnyvale, California, United States Diverse Lynx Full timeJob SummaryWe are seeking an experienced Mobile Device Management Automation Specialist to join our team at Diverse Lynx LLC. This is a full-time position based in Sunnyvale, where you will be working on enterprise-scale applications for iOS and MacOS.Responsibilities:Develop and execute automated test cases for mobile device managementWork independently to...
-
Medical Device Quality Assurance Lead
3 weeks ago
Sunnyvale, California, United States Ihealth Labs Inc Full timeKey ResponsibilitiesThe Quality Manager will be responsible for:Establishing and maintaining our quality management system.Leading cross-functional projects and ensuring compliance with regulatory requirements.Monitoring and evaluating the implementation of the quality system.Supporting matters related to product risk, quality, customer complaints,...
-
Mobile Device Management Test Engineer
4 weeks ago
Sunnyvale, California, United States Diverse Lynx Full timeAt Diverse Lynx LLC, we are seeking a highly skilled Mobile Device Management Test Engineer to join our team. This is a full-time position based in Sunnyvale, California. The ideal candidate will have extensive experience in testing enterprise software applications on iOS and MacOS platforms. A strong understanding of modern web design and debugging...
-
China/HK Regulatory Affairs Expert
3 weeks ago
Sunnyvale, California, United States Intuitive Full timeAbout the RoleThis exciting opportunity plays a critical part in shaping Intuitive Surgical's regulatory strategy in China. As a key member of our team, you'll collaborate closely with colleagues across various functions to drive quality compliance initiatives. With your extensive knowledge of NMPA regulations and quality management systems, you'll develop...
-
Senior Mobile Device Management Specialist
3 weeks ago
Sunnyvale, California, United States Diverse Lynx Full time**Job Title:** Senior Mobile Device Management SpecialistDiverse Lynx LLC, a forward-thinking company, is seeking an experienced Senior Mobile Device Management Specialist to join our team. This role involves ensuring seamless integration of iOS and MacOS applications across the enterprise.As a key member of our quality assurance team, you will be...
-
Senior Mobile Device Management Test Engineer
3 weeks ago
Sunnyvale, California, United States Diverse Lynx Full timeWe are seeking a Senior Mobile Device Management Test Engineer to join our team at Diverse Lynx LLC. Based in Sunnyvale, this role requires a deep understanding of iOS and MacOS platforms.The ideal candidate will have hands-on experience testing use cases specific to iOS/MacOS and Mobile Device Management via manual configuration, MDM or through tools like...
-
GForce Life Sciences Sap Quality Manager
4 days ago
Sunnyvale, California, United States GForce Life Sciences Full timeAbout Our Team:We are a passionate team of professionals who are dedicated to delivering innovative solutions for production and quality management.Job Description:This is an exciting opportunity to join our team as a SAP Quality Management Consultant, where you will be responsible for configuring the SAP QM module and related IMG settings to support...
-
Devices Law Specialist
6 days ago
Sunnyvale, California, United States Amazon Full timeWe are seeking a talented Attorney for Amazon Devices to join our team. As a Corporate Counsel, Devices Legal, you will be responsible for providing legal advice and guidance to our Devices & Services business. This role requires strong technical knowledge and the ability to navigate complex agreements and contracts. If you have a passion for technology and...