Intuitive Surgical Careers

Senior Quality Systems Engineer

US-CA-Sunnyvale, California
Manufacturing & Operations


Job Description

Job: Manufacturing & Operations
Primary Location: United States-California-US-CA-Sunnyvale
Schedule: Full-time
Requisition ID: 182106

Description

Company Description:

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.

Position Objective & Summary:

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

Qualifications

Skills/Experience/Education/Training:

• 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 are an AA/EEO/Veterans/Disabled employer.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.