Intuitive Surgical Careers
Senior Quality Systems Engineer
Primary Location: United States-California-US-CA-Sunnyvale
Requisition ID: 182106
Who is Intuitive Surgical? The numbers tell an amazing story. Learn more about our company.Joining Intuitive Surgical means joining a team dedicated to using technology to benefit patients by improving surgical efficacy and decreasing surgical invasiveness, with patient safety as our highest priority.
The Sr. Quality Systems Engineer will work with business partners and management to sustain and create a Quality Management System (QMS) infrastructure that is compliant, effective, efficient and agile to support a rapidly growing international business model with complex and diverse product lines. Sr. Quality Systems Engineer will lead and support by providing quality & compliance oversight (which includes interpretation, implementations, integrations, improvement and training) for all elements of ISI’s QMS. This role will support the established customer-focused quality and strategy to maintain and improve the health of QMS. The Sr. Quality Systems Engineer will lead and participate in projects to identify/drive continuous improvements of a robust and agile QMS and support facility inspections and audits required by government and regulatory agencies on a global basis.
Roles & Responsibilities:
Additional responsibilities include but are not limited to the following:
• Provides leadership for Quality Systems by running day-to-day operations as well representing Quality Systems on cross-functional projects.• Provide operational support for the development and maintenance of a robust quality systems and compliance team• Lead and facilitates projects for the development, maintenance and improvement of the company’s quality management system with a focus on maintaining robust processes and optimization where feasible.• Support business partners and QSC group in determining risk-based actions and decisions to ensure quality system issues are appropriately escalated and addressed.• Develop, maintain and improve processes and procedures for various processes within the quality management system and where necessary, provides training• Define and manage continuous business improvement initiatives.• Leads or supports other projects at the QSC management team’s discretion
• Bachelor Degree – BS degree in Engineering, Physical or Biological Science, or other technical field• 5+ years’ experience in quality systems, quality engineering, or compliance (or combined experience) in the medical device or other regulated industry• Experience in developing and implementing processes and procedures to comply with regulations and standards across the organization; and providing training• Demonstrated strong leadership and partnership in working with diverse teams for improvements, issue resolution, or projects• Strong organizational, written, and verbal communication skills; plus critical thinking skills and proficient in constructive dialogue• Effective at prioritizing of tasks and responsibilities within a fast-paced, dynamic environment• Effective in collaborating and partnering with all levels of management and displaying an appropriate level of assertiveness• Good understanding of product development lifecycles; design control through post-market surveillance• Applied knowledge of risk management, CAPA, and internal/external audit methodologies• Practiced in presenting to various levels of management• Experience working directly with the FDA, Notified Body, or other governmental agencies (preferred)• Applied knowledge of validation methodologies pertaining to computer system, process and equipment (preferred)
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.