Sr. QA Specialist China/HK

3 weeks ago

Sunnyvale, United States Intuitive Full time
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.
    • 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.
  • Post-Market Surveillance and Compliance:
    • Collaborate with ISI and JV Post-Market teams to establish and maintain processes for:
      • China's Periodic Safety Update Report (PSUR),
      • Annual Self-Inspection 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 non-conformance, corrective actions (CAPAs), and field actions. Initiate EDF as needed.
    • Facilitate ISI responses to health authorities and customers for quality and compliance-related 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:
      • Pre-Audit: Ensure timely implementation of required remediations.
      • In-Audit: Act as a primary host, facilitating discussions with auditors.
      • Post-Audit: Lead responses to findings, secure necessary resources, and ensure action closure.
    • Other External Audits
      • Support other regulatory (non-NMPA) inspections/audits and provide input at cross-functional meetings, including Quality, Compliance, and Post-Market.
  • JV Compliance Support:
    • Participate in periodic JV QMR sessions and provide feedback for improvement
    • Support JV-HK's QMS operations, ensuring alignment with Hong Kong's Medical Device Division (MDD) requirements.
    • Assist in remediation activities for FDA QMS compliance, including support for JV's 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 record-keeping 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 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.
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.
  • Cross-cultural 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 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.

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