Director of Quality Assurance

Director Of Quality Assurance

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

General Responsibilities

• Oversee quality aspects of Intuitive's Fluorescence Imaging program - plan, organize and prioritize work activities based on goals and priorities for QA.
• The candidate will interact with and provide oversight to external Quality consultants as necessary to accomplish programmatic goals. As such, broad knowledge of QA as it pertains to GLP, GCP and GMP is desired.
• Knowledge of ICH and Good Data Practices highly recommended.
• Work closely with the Fluorescence Imaging team (including Document Controls and CMC) and Intuitive's Regulatory and Quality organization to develop and oversee quality activities and ensure that Intuitive's QA standards are met and conform to GCP and GMP regulations.
• Develop, improve, and maintain Quality Management System (QMS) relevant to work performed by Intuitive Fluorescence Imaging, including review and approval of QMS documentation, SOPs, batch record review, and batch disposition.
• Keep up to date with all related quality legislation and compliance issues.
• Utilize guidance documents, international standards, or consensus standards and interpret for guidance.
• Administer the document management system for the department.
• Prepare and assist in annual reports and quality trending reports.
• Monitor, document, and report on the status of the quality levels of, systems and production activities.
• Document internal compliance processes, and prepare materials for submission to regulatory agencies.
• Ensure regulatory rules are communicated through corporate policies and procedures.
• Evaluate quality events, incidents, queries, and complaints.
• Work closely with Intuitive's Quality organization to ensure quality events are thoroughly investigated and product meets Intuitive's quality standards.
• Assist with regulatory inspections and external audits as needed. This includes preparing the staff to establish and maintain adequate processes for hosting regulatory interactions.
• Participate in various cross-functional projects within continuous improvement and new programs.

GMP-related Responsibilities

GCP-related Responsibilities

Qualifications