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Head of Quality Systems Management

2 months ago

Sunnyvale, California, United States Intuitive Surgical Full time
Company Overview

At Intuitive Surgical, we are driven by a singular mission: to enhance lives through minimally invasive care. Our innovative technologies empower healthcare professionals to perform surgeries with unparalleled precision and efficiency. As a leader in robotic-assisted surgery, we are dedicated to cultivating a diverse and inclusive workforce that is committed to addressing the most pressing challenges in healthcare today.
With over 25 years of experience, we collaborate with hospitals and care teams globally to redefine the possibilities in patient care. Our culture thrives on the contributions of individuals from various backgrounds, fostering an environment where every idea is valued. We prioritize inclusion and respect, enabling our team members to excel in their authentic selves.
Our passionate workforce is the cornerstone of our success, characterized by integrity, a strong desire to learn, and a commitment to making a meaningful impact. We invest in our employees' growth, ensuring they can reach their full potential while advancing our mission.
Join us in our commitment to transforming the landscape of minimally invasive care for healthcare professionals and their patients.

Role Overview

Key Responsibilities
The Director of Quality Systems will play a pivotal role within the Quality Systems and Compliance leadership team, overseeing a range of critical functions. The ideal candidate will be instrumental in establishing a robust quality management framework that is compliant, effective, and adaptable to support our expanding international operations and diverse product offerings. Responsibilities include:

  • Developing and implementing programs, guidelines, and procedures related to Quality Systems, including Change Control, Data Management, and Compliance Training.
  • Collaborating with Learning Management teams to create and execute an optimized compliance training initiative.
  • Partnering with cross-functional leaders to promote best practices in change control documentation and records management.
  • Ensuring compliance and effectiveness of international quality systems in alignment with regional regulatory requirements.
  • Assisting in the management of regulatory inspections and external audits, as well as supporting internal audit processes.
  • Defining programs to verify and monitor the effectiveness of the quality system in accordance with applicable regulations.
  • Formulating strategies for continuous improvement of the Quality Systems.
  • Providing training and consultation on quality system regulatory compliance to internal stakeholders.
  • Driving standardization of Quality Systems across the organization.
  • Establishing metrics and key performance indicators to assess the global quality system's effectiveness.
  • Ensuring timely identification and resolution of issues arising from Management Review and Quality System evaluations.
Qualifications

Essential Skills and Experience
Applicants should possess a minimum of 12 years of experience in the medical device industry, with at least 8 years in quality assurance or compliance management roles. Alternatively, candidates with a Master's degree and a minimum of 10 years of relevant experience will also be considered. Additional qualifications include:

  • Proven leadership skills to align priorities and deliver programs effectively.
  • Strong interpersonal abilities with a focus on team development.
  • Expertise in Risk Management practices and regulatory requirements, including FDA QSRs and ISO 13485.
  • Experience managing external regulatory audits.
  • Familiarity with CAPA programs and project management methodologies.

Education Requirements
A Bachelor's Degree is required, with a preference for degrees in Engineering or Science.

Preferred Qualifications
Experience in implementing quality management systems for both medical and non-medical devices is preferred, along with familiarity with eQMS platforms. Certifications such as Six Sigma, RAC, or ASQ are advantageous.

Additional Information

Intuitive Surgical is an Equal Employment Opportunity Employer, committed to providing equal opportunities to all qualified applicants and employees. We prohibit discrimination and harassment of any kind, ensuring a workplace that respects diversity and inclusion.

We offer competitive compensation packages, including base pay, incentives, benefits, and equity. Actual pay will be determined based on various factors, including experience and qualifications.