What are the responsibilities and job description for the Sr. QA Specialist China/HK position at Intuitive Surgical?
Company Description
At Intuitive, we are united behind our mission : we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.
As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.
Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.
Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.
Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.
Job Description
Primary Function of Position
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. The role encompasses QMS compliance throughout the product lifecycle, including remediation planning, execution, and continuous improvement. Success in this position requires expertise in China’s QMS regulations, effective cross-functional collaboration, and proficiency in Chinese (highly desirable).
Essential Job Duties
- China QMS Compliance Management :
Coordinate cross-functional and regional communications to ensure ISI’s QMS compliance in China.
Collaborate with ISI and JV Post-Market teams to establish and maintain processes for :
China’s Periodic Safety Update Report (PSUR),
Ensure timely submission in compliance with NMPA requirements.
Internal Audits : Plan and coordinate internal audits for China QMS compliance, address findings, and drive continuous improvement.
Collaborate with the JV Quality team to manage external communications with regulatory authorities and support routine / flight inspections and audits.
Pre-Audit : Ensure timely implementation of required remediations.
Support other regulatory (non-NMPA) inspections / audits and provide input at cross-functional meetings, including Quality, Compliance, and Post-Market.
Participate in periodic JV QMR sessions and provide feedback for improvement
Manage Regulatory Standards Assessment (RSA) intake for relevant Chinese national and industry standards.
Maintain and update training materials on NMPA QMS regulations and guidance documents.
Qualifications
Required Skills and Experience
Required Education and Training
Working Conditions
Preferred Skills and Experience
Additional Information
Due to the nature of our business and the role, please note that Intuitive and / or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.
Intuitive is an Equal Employment Opportunity / Affirmative Action Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.
EEO and AA Policy
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.
We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed.
Base Salary Range Region 1 : $121,900 - $175,300
Base Salary Range Region 2 : $103,600 - $149,000
Shift : Day
Travel : 10% of the time
Workplace Type : Set Schedule - This job will be onsite weekly, the percentage of onsite work will be defined by the leader.
Salary : $103,600 - $175,300
