Intuitive Surgical Careers

Director, Global Supplier Quality

US-CA-Sunnyvale, California
Regulatory and Quality


Job Description

Job: Regulatory and Quality
Primary Location: United States-California-US-CA-Sunnyvale
Schedule: Full-time
Requisition ID: 180613

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.

Intuitive Surgical is the global leader in the rapidly growing field of robotic-assisted minimally invasive surgery. Since its inception, the company has consistently provided surgeons and hospitals with the tools needed to improve clinical outcomes and to help patients return to active and productive lives. With its corporate headquarters located in Sunnyvale, California, Intuitive Surgical serves customers throughout the United States and internationally, providing technology and procedural innovation across broad surgical disciplines

Summary:

Reporting to the VP, Product Quality, the Director of Global Supplier Quality provides overall quality management of global supplier base engaged in the development, production and distribution of Intuitive Surgical products. This position will partner with independent Supplier Engineering teams, Quality Engineering, Quality Systems & Compliance and global partners to define the overall Supplier Quality Management (SQM) strategy, including developing clear mission, vision, and priority setting. The individual will also be responsible for developing and maintaining a system, and standardized approach to SQM including global policies/procedures, quality agreements, forms/templates and supplier quality metrics etc. that are compliant with all applicable international regulatory requirements (e.g. FDA regulations, ISO 13485, MDSAP, European MDR/IVDR etc.). The Director shall also be responsible for assuring effective coordination of supplier/vendor audits, governance of the Supplier Corrective Action program and management of Approved Supplier List (ASL) in conjunction with global and Business Unit teams.

Responsibilities:

• Establish plan and performance metrics for SQM function in alignment with Intuitive Surgical’s 3 - 5 year objectives
• Support development of suppliers to be: Agile, Tightly integrated with Intuitive Surgical, Capable, and Stable thereby ensuring a reliable and robust supplier base
• Establish a high performing supplier quality team. Provide direction, oversight, coaching and mentoring.
• Identify and implement means to manage work-load, schedule, and monitor performance objectives.
• Collaborate cross-functionally to develop and implement a highly effective supplier quality management program focused on innovative solutions to meet business challenges and deliver maximum value to the business.
• Develop and report key supplier quality metrics to cross-functional management.
• Identify, develop and implement strategic quality initiatives to ensure continuous improvement with respect to supplier quality performance.
• Develop audit plan, manage audit schedule and perform audits and inspection per plan (either internally or by a 3rd party contractor.)
• Perform supplier qualification and assessment activities per established procedures, including initial onboarding, maintaining the supplier files and updating the Approved Supplier List (ASL.)
• Maintain the Approved Supplier List and implement the use of internal quality systems resulting in successful resolution of supplier quality problems and performance issues
• Continually evaluate and report on supplier quality performance, identify problem areas and assist with implementing supplier corrective actions as required.
• Perform other duties as assigned.
Qualifications

Skill/Job Requirements:

• B.S. Degree in an engineering field or other applicable discipline is required.
• Minimum of 12+ years of engineering, manufacturing or quality experience required. Medical device or pharmaceutical industry strongly preferred, experience with electromechanical Devices is preferred
• 8+ years in managing Global Supplier Quality Management programs. Preferably, in the medical device, pharmaceutical, robotics, automotive or aerospace industries. Six-sigma certification and prior auditing experience to FDA QSR and ISO standards is preferred
• Demonstrated experience in technical or manufacturing operations, product quality investigations and supplier management
• Lead Auditor training and knowledge of advanced audit practices
• Strong leadership, program management, negotiation and interpersonal skills
• Demonstrated record of success in achieving results and influencing others to achieve corporate, site, and departmental objectives
• Excellent communication skills
• Demonstrated ability to: interact with and gain the support of senior management, global partners, and cross functional teams
• Demonstrated ability to effectively manage multiple, complex priorities
• Demonstrated ability to understand data sets and drive to data-based decision
• Ability to travel domestic and globally 10-25%.


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.


Primary Work Location: Sunnyvale, CA


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