Job Description

Company DescriptionAt 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.Primary Function of PositionReporting to the Sr, Director of RAQA Audits, 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 separate 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 personal 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.Essential Job Duties

• Establish plan and performance metrics for SQM function in alignment with Intuitive Surgical\'s 3-5 year priorities
• 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 targets.
• 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.

QualificationsRequired Skills and Experience

• Minimum experience of 12+ years of engineering, manufacturing or quality experience in a regulated environment is required.
• Minimum 8+ years in managing Global Supplier Quality Management programs. Preferably, in the medical device, pharmaceutical, robotics, automotive or aerospace industries.
• Demonstrated experience in technical or manufacturing operations, product quality investigations and supplier management
• Excellent leadership, program management, negotiation and interpersonal skills
• Demonstrated record of success in achieving results and influencing others to achieve corporate, site, and departmental goals
• 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 conclusion
• Ability to travel domestic and globally 25-50%.

Required Education and Training

• Minimum Education: Minimum B.S. Degree in an engineering field or other applicable discipline is required.
• Lead Auditor training and knowledge of advanced audit practices in ISO standards and/or FDA Regulations

Preferred Skills and Experience

• Medical device or pharmaceutical industry highly preferred, experience with electromechanical Devices is preferred
• Six-sigma certification and prior auditing experience to FDA QSR and ISO standards is preferred

Additional InformationDue to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed.Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed.

Intuitive Surgical