Job Description

Primary Function of Position:

The 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 administrative mentoring across interdepartmental boundaries as related to development and manufacturing of high quality, minimally invasive robotic surgical equipment. This key management role will be challenged to effectively lead the quality resources required to support business growth sales demand through the successful introduction of new products. Proven experience achieving results through others and managing wide range of individuals is required. Quality performance track record in a medium to large-scale medical device manufacturing, new product introduction, and scale-up is preferable.

Essential Job Duties:

• Identify, investigate, properly document, and implement quality improvements and initiatives for both product and process; coach others in doing the same. Drive these issues through quality system vehicles such as CAPA, PPIR, HHA, VR, NCR, etc.
• 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.)
• Creates vision, strategy, and tactics which effectively integrates multidisciplinary strategies enabling seamless execution and goal obtainment.
• Creates an environment that is inclusive and diverse allowing employees to be their authentic selves, while motivating them to produce their best work.
• Lead with inclusion and build a diverse workforce that models and champions Intuitive Surgical' s culture and value setFoster 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.
• Lead NPI facing Quality Engineering function.
• Lead NPI Quality team to define and improve reliability of new products.
• Establish and lead the COE organization for Risk Management, Design Control, and Quality Notifications.
• Build and inspire a highly motivated team by attracting, hiring, training, developing and retaining top Quality talent
• Deploy technically competent Quality Engineers and other quality professionals to provide quality-based deliverables to the Design Control process and on-going operations, including but not limited to the following: Master Validation Plans, dFMEA, pFMEA, inspection plans, critical component evaluations, product and process validations, etc.
• Ensure full participation of Quality Engineering with NPD and NPI functions.
• Ensure design compliance with applicable medical device standards.
• Create and maintain Quality Manual components under the purview of the position.
• Continuously improve product cost, quality, delivery, and service levels
• Highly skilled at translating strategic, financial and technical content into a clear sense of purpose that effectively engages multiple teams (within and outside direct span of influence).
• Develops strong and enduring relationships internally and externally through consistent use of sophisticated communications.
• Support other Quality and/or Regulatory efforts as required.