Head of Quality & Compliance, Monarch Platform

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Job Function:
Quality

Job Sub Function:
Multi-Family Quality

Job Category:
People Leader

All Job Posting Locations:
Santa Clara, California, United States of America

Job Description:

Job Summary:

Auris Health, a member of Johnson & Johnson's Family of Companies, is recruiting for Head of Quality and Compliance (Q&C) Leader for our Monarch platform.  This role will directly report to Global VP of Q&C Robotics and Digital Surgery and will be in Santa Clara, California. 

This role is an end-to-end role with responsibilities including Design & Development, Manufacturing/Operations, Quality & Compliance and Post Market Surveillance.

As a leader, you will drive exceptional Quality and Compliance including focus on customer safety and product design, and manufacturability and reliability throughout the Product Development, Operations, Distribution, and Commercial processes.

The leader will have direct quality influence on components, assemblies, final products, suppliers, including R&D and production builds and product release for testing and commercialization.

They will work with a team of quality associates, engineers and managers and will actively lead quality & compliance-based requirements for risk management, design concepts & specifications, design for quality and manufacturing requirements, process/technology development, product verification/validation, manufacturing, supplier controls, post market surveillance, project planning, and associated Quality Management System processes.

The Head of Monarch Q&C will partner closely with cross functional teams including but not limited to R&D, Supply Chain/Manufacturing, Clinical and Medical Affairs, Regulatory Affairs, Service, Marketing, in furthering new product development, manufacturing, delivery and market releases.  They will be responsible for leading and working with Monarch Quality & Compliance (Q&C) teams in continuously implementing and maintaining a compliant, scalable, agile and effective QMS.  They will actively work with Global VP Q&C Robotics to develop and shape the multi-year Q&C strategy applicable to Monarch and RAD and manage and partner on key strategic initiatives/programs across Q&C and platforms to focus on continuous business growth and improvements.

The leader will drive compliance and accountability for Quality Management Systems within Monarch Platform including successful execution of Internal/External Audit program in partner...