Sr. Director Quality Operations

Company Description

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.

Primary Function of Position:

Manages and coordinates all activities of personnel engaged in Quality Operations functions at Intuitive locations worldwide. Responsibilities that report into this role include Incoming Quality Control (IQC), Material Review Board (MRB), Preventive Maintenance & Calibration (PMC), Final Quality Inspection (FQI), and Product Release (DHR), to ensure adherence to company quality standards. The Sr. Director will ensure the following:

• DHR: Review and approve manufacturing device history records, ensuring compliance with device master record and other quality system requirements.
• FQI: Perform final release testing on product
• IQC: Perform dimensional and visual inspections of purchased parts, assemblies and products to required specifications.
• PMC: Execute/facilitate preventive maintenance and calibration needs of all equipment, fixtures and tools per released instructions.
• MRB: Oversee and facilitate the non-conforming material process.

In addition, the Sr. Director will lead continuous improvement, training, and CMM programming activities within the Quality Operations team.

Roles & Responsibilities

• Proactively manages quality assurance and compliance activities in order to produce the highest quality products and prevent defects.
• Collaborates with the operations teams as well as other internal and external partners to ensure the strategy is executed to achieve significant and measurable results.
• Establish, align, and monitor Quality Operations CIP/department goals with BU and site(s).
• Creates an environment that is inclusive and diverse allowing employees to be their authentic selves, while motivating them to produce their best work.
• Foster an inclusive culture built around diversity of thought, collaboration and teamwork across organizational and geographical boundaries; willing to break down functional silos to optimize business results and to facilitate the overall growth of the company.
• Assures that manufacturing quality and performance data are comprehensively measured, trended, reported, and acted on in a timely manner to ensure compliance and support continuous improvement.
• Create, monitor, and control the quality operations budget.
• Ensures operator performance is measured and routinely monitored.
• Lead the strategic resource planning efforts for the quality operation and support operations capacity modeling.
• Develops teams to support business unit and plant level organizational structure.
• Creates the global quality operations strategy ensuring alignment with site quality and cross functional partner objectives.
• Perform periodic audits to verify correct and consistent operations and act as SME for Quality Operations during internal and external audit / inspection.
• Develop, trend, and improve appropriate quality operational metrics.
• Collect, monitor, and escalate product quality data and partner with the appropriate function to resolve problem parts, supplier, processes, etc. to closure.
• Ensures quality operators routinely demonstrate compliance with all elements of the QMS.
• Monitor and facilitate effective work relationships for inspectors, operators, and cross functional partners.
• Facilitates behavioral based quality program along with continuous improvement and kaizen oriented suggestive systems.
• Track recurring issues and escalate as needed to achieve root cause corrective action.
• Manage the Quality Operations leadership team across Intuitive locations globally.

Qualifications

Skills, Experience, Education, & Training:

• Working knowledge of Geometric Dimensioning and Tolerance and ability to read technical drawings
• Must be knowledgeable of standard inspection tools, gauges, optical comparators and various types of coordinate measuring machines effectively
• Must be familiar with sampling procedures and tables for inspection by attributes.
• Outstanding management and communication skills.
• Working knowledge of quality tools: measurement repeatability systems, process control tools (Statistical Process Control)
• Must be computer literate with experience using; Windows, Excel, Word, and database programs such as Filemaker Pro or Access.
• Minimum Bachelor of science degree and a minimum of 10 years of management experience.
• In-depth knowledge of Lean / Six Sigma.
• Must have a working knowledge of MRB related activities.
• Must have prior experience acting as a SME for internal and external audit/inspection
• Experience in Medical Device industry and knowledge of Good Manufacturing Practices

Additional Information

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.

Base Salary Range Region 1:$212,000 - $318,000

Base Salary Range Region 2: $180,200 - $270,400

Shift: Day

Travel: 10% of the time