Head of Quality & Compliance, Monarch Platform (Santa Clara)

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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 partnership with RAD/Medtech teams and business functions, manage audit/inspection outcomes with Notified Bodies and FDA, lead and drive effective oversight of CAPA Program and drive accountability to various quality based KPIs. As part of continuous transformation, the leader will ensure Monarch Q&C teams remain focused on transforming RAD based QMS processes to Fit for Purpose and scale up business needs by delivering on next phase on effective, reliable, agile, compliant and scalable QMS.

Sr. Director, Quality & Compliance; Monarch Platform will:

• Act as a strategic thought partner with Monarch platform business leaders in the development of the business strategy and will effectively link the Quality objectives to the business strategy.
• Focus on implementation of policies and strategies for Quality Management Systems to ensure compliance with regulations and industry standards including customer safety and satisfaction and regulatory compliance with business objectives.
• Prioritize and resource benchmarking activities and participate in best business practice sharing internally across Johnson & Johnson and externally to drive competitive advantage.
• Demonstrate an ability to understand current and emerging regulations and approaches for clinical research involving clinical trials and existing requirements for sponsors of clinical investigations involving medical devices.
• Partner with Operations and Process Excellence to set strategies that drive continuous improvements for the customer and championing initiatives across platform that incorporates risk management, process excellence and transformation activities to align business benefits with action and resource prioritization.
• Recruit and continue to develop Quality and Compliance professionals while focusing on technology-driven competencies, leadership-based behaviors with end-to-end accountability modeling.
• Develop and set strategic direction for quality and compliance that integrates customer, product and market requirements to meet the goals of the franchise.

JOB EXPERIENCE

• 20 + years in developing, implementing, applying, and managing design and development, manufacturing, and quality management systems in regulated industry with at least 12 years in a medical device industry.
• A minimum of 10 years is required as a quality leader, including 6 or more years as Director or above in a quality function across Design and Development including End-to-End Quality & Compliance in Medical Device.
• Must have a minimum of 5 years of large-scale Capital Medical Device Equipment experience as a quality leader with a focus on design and development and product quality and reliability including product software (embedded/non-embedded), and manufacturing, product distribution, post market surveillance, and product servicing.
• Experience with design and development and/or manufacturing Robotic Surgical Systems and/or manufacturing assist Robotic systems is highly preferred.
• Proven experience with the application of Design Controls, Statistical Methods, Quality Engineering and Management principles, and Risk Management with exposure to supply chain, operations, post market surveillance is required.
• Good expertise in various standards and regulations including but not limited to 21 CFR Part 820, EN ISO 13485, 21 CFR 803/810, IEC 62304, 21 CFR part 11 and good working knowledge of EUMDR/MDSAP, SOR/98-282, Health Canada, MHLW, TGA, and other international regulations.
• Strong hands-on working knowledge of risk management and electrical safety standards including EN ISO 14971 and IEC 60601.
• Must have demonstrated and implemented Quality Based improvement programs including scalable and integrated quality management systems and shown strong capability to resolve quality and compliance remediation across quality management systems.
• Proven track record of leading and facilitating successful audits and inspections with regulatory bodies including FDA and various Foreign Government Health Authorities and Notified Bodies.
• Strong knowledge of and application to Product Human Factors, Usability Engineering and Product Reliability.
• Must have clearly demonstrated being an effective leader for people development and talent growth.
• Experience with SaMD, optical/imaging devices and systems including Cybersecurity is desirable.

KEY SKILL/LEADERSHIP REQUIREMENTS:

• Influence management, collaboration, and leading cross-functional teams during complex capital medical device product reviews including building solutions and consensus to achieve risk-based outcomes.
• Analytical in solving problems and achieving quality and business objectives by demonstrating innovative approaches to Quality Engineering applications and efficiencies.
• Show capability to both be a strategic leader and be able to deep dive into critical situations.
• Cleary show strategic and focused vision mindset in developing and projecting mid to long term functional strategies and transformational activities.
• Demonstrate experience in leading and developing individuals and teams and be proficient as a leader consistent with Johnson & Johnsons Leadership Imperatives and Credo.

KEY JOB RESPONSIBILITIES:

• Provide vision and leadership in the identification, design, and implementation of best-in-class quality management and engineering systems to support product life cycle management with focus on prevention and detection of defects at the earliest phase of product design, and manufacturing, resulting in right the first-time customer satisfaction.
• Facilitate interaction and transfer of knowledge between product development, operations / manufacturing, external contract manufacturers, and component / raw material suppliers.
• Responsible for building capability and competency of organization and leading engineers and people leaders to create effective Quality Engineering processes at all levels and throughout the organization.
• Develop and mentor Engineers and people leaders throughout the organization including matrix organizations such as R&D/New Product Development and Operations to create and sustain a strong talent pipeline.
• Partner with key stake holders including but not limited to R&D, Operations, Commercial, Supply Chain, Regulatory Affairs, Medtech/Enterprise, to assure quality and business deliverables and metrics are met.
• Identify systemic product and process improvement opportunities assuring appropriate investigation, correction, corrective and preventive action where needed.
• Demonstrate an ability to in]]>