Sr QA Specialist ChinaHK - NMPACFDA

Primary Function of Position

The Sr. QA Specialist China/HK will play a pivotal role in ensuring Intuitive Surgical Inc. (ISI) complies with Chinas National Medical Products Administration (NMPA) Quality Management System (QMS) requirements. This position supports ISIs 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 Chinas QMS regulations effective crossfunctional collaboration and proficiency in Chinese (highly desirable).

Essential Job Duties

• China QMS Compliance Management:
  • Coordinate crossfunctional and regional communications to ensure ISIs 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 crossfunctional implementation plans via the change management system.
  • Provide guidance and training on manufacturing and engineering activities from a China/HK quality perspective.
• PostMarket Surveillance and Compliance:
  • Collaborate with ISI and JV PostMarket teams to establish and maintain processes for:
    • Chinas Periodic Safety Update Report (PSUR)
    • Annual SelfInspection Report
    • ADR Inquiry Response.
      Ensure timely submission in compliance with NMPA requirements.
  • Conduct complaint trend analysis and monitor adverse events (AE) to ensure timely reporting as per regulatory and internal requirements.
  • Support investigations of nonconformance corrective actions (CAPAs) and field actions. Initiate EDF as needed.
  • Facilitate ISI responses to health authorities and customers for quality and compliancerelated queries. Support authority inspections happened at customer sites as needed.
• Internal and External Audits and Communications:
  • Internal Audits: Plan and coordinate internal audits for China QMS compliance address findings and drive continuous improvement.
  • JV Audits:
    • Collaborate with the JV Quality team to manage external communications with regulatory authorities and support routine/flight inspections and audits.
    • Support JV audits of ISI as a supplier and ISI audits of the JV as a contract manufacturer and distributor.
    • Assist in audits related to Chinese labeling activities.
  • NMPA Overseas Audits:
    • PreAudit: Ensure timely implementation of required remediations.
    • InAudit: Act as a primary host facilitating discussions with auditors.
    • PostAudit: Lead responses to findings secure necessary resources and ensure action closure.
  • Other External Audits
    • Support other regulatory (nonNMPA) inspections/audits and provide input at crossfunctional meetings including Quality Compliance and PostMarket.
• JV Compliance Support:
  • Participate in periodic JV QMR sessions and provide feedback for improvement
  • Support JVHKs QMS operations ensuring alignment with Hong Kongs Medical Device Division (MDD) requirements.
  • Assist in remediation activities for FDA QMS compliance including support for JVs registration as a US FDA Contract Manufacturer.
• Regulatory Intelligence:
  • Manage Regulatory Standards Assessment (RSA) intake for relevant Chinese national and industry standards.
• Training and Education:
  • Maintain and update training materials on NMPA QMS regulations and guidance documents.
  • Conduct regulatory and quality training for ISI staff to enhance awareness and ensure compliance. Ensure timely training completion and accurate recordkeeping for all stakeholders.

Qualifications :

Required Skills and Experience

• 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 crossfunctional 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.

Required Education and Training

• Minimum Education: B.S./B.E. or higher in life science biomedical engineering or related filed.
• Advanced degree preferred.

Working Conditions

• Flexible hours to support the international nature of the job

Preferred Skills and Experience

• Previous China regulatory affairs experience a major plus.
• Knowledge of SAP Agile or similar business systems desired.
• Mandarin speaking a major plus.
• Crosscultural project experience a plus.

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 COVID19.  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 marketcompetitive 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.

Remote Work :

No

Employment Type :

Fulltime