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.
Job Description
Primary Function of Position
This person manages a Quality Engineering group, and grows an organization that is equipped to reach across the company acting as emissaries for the Product Quality mission. Quality Engineering is responsible for developing quality metrics and helping the company applying them intelligently and consistently. Quality Engineering is broadly responsible for, or a stake-holder in Product Quality; Data Quality; Process Quality; Solutions to challenging quality problems; Design for Quality in new product; Organizational input to QRB; Organization of Enterprise data for quality.
The Quality Engineering Manager is responsible for managing the team of Quality Engineers and evaluating their results. Coordinates the support to production released assembly lines in Mexicali Operations. He or she interfaces with leaders including VPs and Directors throughout the design, operations, regulatory, IT, marketing and service areas of Intuitive Surgical.
Essential Job Duties
This position has responsibility and authority for:
- Manage group of Quality Engineers and support them through their day to day responsibilities
- Oversees the preparation of the Quality metrics presentations for QDR / QOR Meetings and analyzes the data to obtain conclusions to define proper action plans for continuous improvement
- Assess issues and Escalates based on criticality.
- Liaison with other Quality functions representatives in other Intuitive locations and with other company functions as it applies.
- Represents the Quality Engineering function in projects of medium to high complexity, Escalation Processes, CAPA's, External and Internal audits.
- Defines the Quality Engineering organizational structure to provide the required support.
- Anticipates future needs in order to adequate the organizational structure according to company growth / changes.
- Identifies opportunities for improvements on Product Quality, Processes Efficiency, Cost Reduction, and coordinates the team of QE's for the implementation of these opportunities to achieve our company goals.
- Defines and executes the development plans for the Quality Engineering team under her or his responsibility, establishing and documenting development goals and tracking its progress.
- Serving and proponent for quality across enterprise
- Providing metrics and guidelines to functions to assist in trending and improving quality
- Applying metrics to measure quality and metrics to trade quality off against other attributes of a successful enterprise (“cost of quality”)
- Maintaining a prioritized list of quality initiatives on three levels
- Product quality - Analysis of product failures and reliability opportunities; metrics; deep failure analysis; assistance in project management of projects that address said failures; metrics of improvement
- Data quality - Understanding and analysis of how the enterprise acquires and processes raw data to derive action priorities and plans; development of data quality vision and negotiation for the gradual adoption of that vision throughout the enterprise. This requires understanding of how IT and Operations manage and input quality data, as well as cost-benefit trade-offs for potentially costly “perfect data”.
- Process Quality - analysis of processes that affect product quality, or guidance to others to analyze their processes.
- Project management help for a series of Product, Compliance and Quality projects.
- Supporting New Product Introduction initiatives by assessing Quality Engineering resources needed and allocation.
- Support for deep technical failure analysis and analysis of challenging quality issues
- Generation of input for QRB, including managing the quality of other organizations’ input.
- Review of quality data collected regularly and setting of priorities
- Bioburden / Endotoxins and CER performance data trending analysis review and reporting.
- Gathering and making available to enterprise customers a routine set of quality data for their weekly use (standard quality reports)
- Revision and approval of internal documentation, including:
- Engineering Change Orders (ECO's, BCO's, NCO's, MCO's, etc.)
- Work instructions (MPI's, IVI's, QAP’s, Acceptance criteria, etc.)
- Operating procedures (SOP's, DOP's, etc.)
- Validations (IQ, OQ, PQ, PPQ)
- Take responsibility for developing and maintaining compliance with the quality system.
- Review and assign priorities to Quality Engineers when production line support is required.
- Support on the implementation of assembly lines or product transfers into our facilities, including planning, validation/verification and final implementation.
- Drive our Culture Strategy by fostering our mission, founding principles, individual and leadership expectations.
Qualifications
Required Skills and Experience
- Impeccable integrity
- 5 years experience in the quality arena of medical device manufacturing, or equivalent quality background
- Proven ability to build and manage teams and to project-manage cross-functionally
- 2 years experience managing groups of professionals.
- Strong analytic skills as proven by track record for analyzing and fixing complex problems in products and processes
- Training or commensurate experience in the science of quality
- Demonstrate strong leadership skills to coordinate and coach reporting engineers.
- Proven ability to lead and motivate across functional boundaries
- Proven ability to manage through conflicting requirements and make difficult trade-offs when resources are scarce.
- A passion for doing the vital thing, efficiently and well
- Excellent judgment in the presence of competing priorities and incomplete data
- Possess strong communication skills to interact with suppliers, other departments within the company (Supplier Engineering, New Product Introduction, Planning, Purchasing, Regulatory, Product Quality, etc., in both Sunnyvale and Mexicali sites)
- English Level +80%
Required Education and Training
- Education: BS in Engineering Master’s degree (preferred) or equivalent experience
Preferred Skills and Experience
- MS in an engineering discipline.
- Lean Six Sigma training.
Additional Information
Intuitive es un empleador que brinda igualdad de oportunidades de empleo. Proporcionamos igualdad de oportunidades de empleo a todos los solicitantes y empleados cualificados, y prohibimos cualquier tipo de discriminación y acoso, independientemente de su raza, sexo, condición de embarazo, orientación sexual, identidad de género, origen nacional, color, edad, religión, condición de veterano protegido o de discapacidad, información genética o cualquier otra condición protegida por las leyes federales, estatales o locales aplicables.
Shift: Day
