Global Quality Compliance Specialist
3 weeks ago
The 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 Fosun Pharma, and drives NMPA regulatory compliance efforts.
Responsibilities:
• Coordinate cross-functional and regional communications to ensure ISI's QMS compliance in China.
• Identify and address gaps in the established QMS to align with relevant Chinese regulations.
• Monitor new NMPA regulatory requirements related to quality systems and communicate updates to stakeholders.
• Assess change proposals for risk and regulatory impact; coordinate cross-functional implementation plans via the change management system.
• Provide guidance and training on manufacturing and engineering activities from a China/HK quality perspective.
Requirements:
• Minimum 8+ years of working experience in Quality System or related field, minimum 5 years in 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 quality and compliance systems with limited oversight.
• Excellent analytical and strategic thinking skills.
• Strong project management skills.
• Previous audit management experience a must (NMPA audit a plus).
• Excellent written and verbal communication skills a must.
• Excellent negotiation skills and the ability to work effectively in cross-functional and multicultural teams.
• Highly proficient in Microsoft Word, Excel, and Project applications.
• Knowledge of SAP, Agile, TrackWise or similar business systems desired.
• Must be willing to travel internationally once company travel is approved.
Salary Range:$120,000 - $160,000 per year.
-
Regulatory Compliance Specialist
4 days ago
Sunnyvale, California, United States Kelly Science, Engineering, Technology & Telecom Full timeAbout the RoleWe are seeking a highly skilled Regulatory Compliance Specialist to join our team at Kelly Science, Engineering, Technology & Telecom. As a key member of our global change control process, you will play a crucial role in ensuring the accuracy and compliance of client's in vitro diagnostic products.This is an excellent opportunity for a...
-
Quality Assurance Specialist
4 weeks ago
Sunnyvale, California, United States Insight Global Full timeJob Overview: Insight Global is a national retail client seeking a skilled Quality Engineer to join their growing team. The ideal candidate will have experience in end-to-end testing on multiple platforms, including web and mobile applications.">Daily Responsibilities:Creating defects and monitoring automated testsParticipating in scrum meetings and...
-
Regulatory Compliance Specialist
4 weeks ago
Sunnyvale, California, United States Ihealth Labs Inc Full timeKey ResponsibilitiesThe Regulatory Compliance Specialist will be responsible for ensuring compliance with FDA and ISO 13485 quality system regulations and requirements.This includes internal and external quality audits, organizing/conducting internal audits and management reviews, hosting external audits, and following up on audit findings and management...
-
Global Security Operations Specialist
4 weeks ago
Sunnyvale, California, United States Fortinet Full timeJob DescriptionFortinet is a pioneering cybersecurity company looking for a skilled Global Security Operations Specialist to join its rapidly growing business. As a key member of the Security Operations Center (SOC) team, you will be responsible for monitoring and analyzing security events, developing threat detection strategies, and collaborating with...
-
Senior Compliance Oversight Specialist
4 days ago
Sunnyvale, California, United States Optima Partners Full timeJob DescriptionOptima Partners is seeking a highly skilled Senior Compliance Oversight Specialist to provide senior oversight of client regulatory compliance matters for asset managers, hedge funds, private equity, venture capital, BDCs, real-estate, credit managers, banks, and broker-dealers.The ideal candidate will have a deep understanding of regulatory...
-
Compliance and Quality Expert
4 weeks ago
Sunnyvale, California, United States Intuitive Full timeResponsibilitiesThe successful candidate will be responsible for coordinating cross-functional and regional communications to ensure our QMS compliance in China. They will identify and address gaps in the established QMS to align with relevant Chinese regulations.They will also monitor new NMPA regulatory requirements related to quality systems and...
-
Automated Testing Specialist
2 days ago
Sunnyvale, California, United States Saxon Global Full timeJob Summary:Saxon Global is seeking an Automated Testing Specialist to join our team. As a key member of our quality assurance department, you will be responsible for designing, building, and innovating a detailed automation framework and methodology for testing end-to-end, from frontend to backend, including mobile clients.About the Role:We are looking for...
-
Senior iOS Quality Assurance Specialist
4 weeks ago
Sunnyvale, California, United States Saxon Global Full timeWe are searching for a Senior iOS Quality Assurance Specialist to work in our office in Sunnyvale, CA or Seattle, WA. This position requires 1-2 days onsite from day one.The estimated salary for this role is $60/hr on C2C.About the Role:The successful candidate will be responsible for designing and building a detailed automation framework and methodology for...
-
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...
-
Hadoop Developer Specialist
4 weeks ago
Sunnyvale, California, United States Saxon Global Full timeJob Title: Hadoop Developer SpecialistSaxon Global is seeking a skilled Hadoop Developer Specialist to join our team. The ideal candidate will have hands-on experience in designing, implementing, and supporting big data solutions using Hadoop.The estimated salary for this position is $100,000 - $160,000 per year, depending on location and experience.Job...
-
Medical Device Quality Engineer
3 weeks ago
Sunnyvale, California, United States Intuitive Full timeOur CompanyIntuitive is a global leader in robotic-assisted surgery, committed to advancing the world of minimally invasive care. With a strong focus on innovation and patient outcomes, we strive to create technologies that empower surgeons to heal without constraints.As a Quality Assurance Specialist, you will play a critical role in ensuring the quality...
-
Saxon Global Java Backend Engineer
4 days ago
Sunnyvale, California, United States Saxon Global Full timeCompany OverviewSaxon Global is a leading professional services firm with expertise in IT and consulting. Our team is committed to delivering high-quality solutions that meet our clients' needs.Job DescriptionWe are seeking an experienced Java Backend developer to join our Ecommerce team in Sunnyvale. As a member of our team, you will be responsible for...
-
Data Compliance Specialist
4 weeks ago
Sunnyvale, California, United States Goli Tech Full timeJob OverviewGoli Tech is seeking a skilled Data Compliance Specialist to join our Marketplace Partner Payments Financial Operations team. This role will be a key contributor to our payment compliance initiatives, working closely with stakeholders to understand the seller journey and data management processes.About the RoleThis position involves partnering...
-
Network Quality Assurance Specialist
4 weeks ago
Sunnyvale, California, United States Nokia Full timeAbout UsNokia is a global leader in the development of innovative technologies. Our mission is to create value for communication service providers and enterprise customers by leading the transition to cloud-native software and as-a-service delivery models. Our team of experts works together to push the limits of what is possible and make a positive impact on...
-
Java Application Specialist
4 weeks ago
Sunnyvale, California, United States Saxon Global Full timeAbout the JobAs a Java Application Specialist at Saxon Global, you will play a critical role in the development and implementation of web-based Java applications. This is an excellent opportunity for those who enjoy working with technology and are passionate about delivering high-quality results.Key ResponsibilitiesYour key responsibilities will...
-
Software Quality Control Professional
3 weeks ago
Sunnyvale, California, United States Insight Global Full timeJob Title: Quality EngineerJob Summary: We are seeking a skilled Quality Engineer to join our team. The successful candidate will have experience in end-to-end testing on multiple platforms, including web and mobile applications.Duties and Responsibilities:Conducting E2E testing on multiple platformsCreating defects and monitoring automated...
-
Global Supply Chain Acquisition Manager
3 weeks ago
Sunnyvale, California, United States IntelliPro Group Inc. Full timeJob DescriptionWe are looking for a highly skilled Procurement Specialist to join our team at IntelliPro Group Inc. in Sunnyvale, CA.This contract position offers a competitive hourly rate of $33.85 per hour, paid on a w2 basis.The successful candidate will have 2+ years of procurement experience and a strong background in Mandarin communication.Main...
-
Automation Framework Specialist
2 days ago
Sunnyvale, California, United States Saxon Global Full timeAbout Saxon Global:We are a dynamic and growing company that values creativity, collaboration, and customer satisfaction.We are seeking a talented Automation Framework Specialist to join our team. In this role, you will be responsible for designing, developing, and maintaining automated testing frameworks using various tools and technologies.
-
Sunnyvale, California, United States Saxon Global Full timeSaxon Global is hiring an Automated Testing and Quality Assurance Professional to work in our office in Sunnyvale, CA or Seattle, WA. This is a hybrid role that requires 1-2 days onsite from day one.The estimated salary for this role is $60/hr on C2C.About the Job:The Automated Testing and Quality Assurance Professional will design, build, and innovate a...
-
Chief Compliance Officer
23 hours ago
Sunnyvale, California, United States Synopsys Full timeOverview of the Role">The Chief Compliance Officer will be responsible for leading a broad range of internal investigations related to potential violations of company policy and/or law in APAC. This includes partnering cross-functionally to drive programmatic improvements to our global ethics and compliance program, including enhancements to policies,...