Sr. Director Quality Engineering

Job Description

Primary Function of Position:

The Sr. Director, Quality Engineering will be a key member of the Product Quality leadership team with broad responsibilities. The person in this position will provide leadership, technical and managerial mentoring across interdepartmental boundaries as relates to the development and manufacturing of high-quality, minimally invasive robotic surgical equipment.

This key leadership position manages and coordinates all activities related to Quality Engineering functions for a BU in Sunnyvale, CA.  Responsibilities that report to this role are NPI and Sustaining Quality Engineering functions.

Roles & Responsibilities:

• Manage the Quality Engineering leadership team across relevant Intuitive locations focused on providing high quality deliverables to the Design Control process and on-going operations, including but not limited to: Master Validation Plans, dFMEA, pFMEA, inspection plans, critical component evaluations, product and process validations, etc.
• Creates vision, strategy, and tactics which effectively integrates multidisciplinary groups enabling seamless execution and goal obtainment.
• Provide oversight, training, and direct review of the generation of quality documents and records related to implementation and/or compliance with medical regulations (i.e. CFR 820, ISO 13495, et al.)
• Establish, align, and monitor 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.
• Build and inspire a highly motivated team by attracting, hiring, training, developing and retaining top Quality talent.
• Proactively manages quality assurance and compliance activities in order to produce the highest quality and reliability products.
• Facilitates and manages product / process escalations, including manufacturing and post market risk management escalations. 
• Create, monitor, and control the BU Quality Engineering budget.
• Monitor and facilitate effective work relationships with cross functional partners.
• Ensures the business unit routinely demonstrates compliance with all elements of the QMS.
• Ensures operator performance is measured and routinely monitored.
• 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.
• 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.
• Perform periodic audits to verify correct and consistent operations and act as SME for Quality Engineering during internal and external audit / inspection.
• Track recurring issues and escalate as needed to achieve root cause corrective action.
• Collect, monitor, and escalate product quality data and partner with the appropriate function to resolve problem parts, supplier, processes, etc. to closure.
• Develop, trend, and improve appropriate BU, product, and functional metrics.
• Develops strong and enduring relationships internally and externally through consistent use of sophisticated communications.
• Support other Quality and/or Regulatory efforts as required.

Qualifications

Skills, Experience, Education, & Training:

• Must be knowledgeable of design, production and process, risk management, and other relevant GMP processes.
• Must have prior experience acting as a SME for internal and external audit/inspection.
• Strong technical analytical skills including FMEA, statistical methods, Six Sigma technique, inspection sampling techniques, Geometric Dimensioning and Tolerance, etc.
• Must have a working knowledge of NCR, MRB, product holds, and other NC material control related activities.
• Experience in Medical Device industry and knowledge of Good Manufacturing Practices
• Working knowledge of quality tools:  measurement repeatability systems, process control tools (Statistical Process Control)
• In-depth knowledge of Lean / Six Sigma.
• Must be computer literate with experience using; Windows, Excel, Word, and database programs such as Tableau, Snowflake, Access, etc.
• Previous Medical Device manufacturing experience highly desirable
• Must be willing to relocate to Sunnyvale, CA

Required Education and Training

• Minimum BS in engineering sciences or equivalent, advanced degree in Engineering preferred.
• Minimum 16 years’ experience in medical Design, Quality, Manufacturing and/or Engineering.
• Minimum 8+ years management experience