Senior Director, BWI Quality & Compliance

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

People Leader

All Job Posting Locations:

Irvine, California, United States of America

Job Description:

Johnson & Johnson is recruiting for a Senior Director, BWI Quality & Compliance to support our Cardiac Electrophysiology business. The role is based in Irvine, CA.

POSITION SUMMARY

Head of Quality, responsible for ensuring effective implementation of BWI Quality Management System.

RESPONSIBILITIES

In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

• Leads BWI Worldwide Quality functions, setting the strategies and goals in accordance with applicable regulatory requirements. Johnson and Johnson Enterprise, Medical Device and CSS policies and goals.
• Product Quality – Oversees directly and indirectly organization of Quality professionals, such as engineers and scientists that focus on quality aspects of development, lifecycle, supply chain, production and support. Includes partnership in new product development and leadership in supplier qualification, product release, field actions and complaint resolution activities.
• Quality Services – Leads effective establishment of organizations that support business process and compliance, quality risk management, design assurance, internal audits, corrective and preventive action, records management and document control, complaint management and medical device reporting and management of quality data across disciplines.
• Management Representative – Provides management with executive responsibility with objective evaluation of overall BWI Worldwide Quality performance and provides leadership and guidance for implementation of improvements, corrective and preventive actions.
• Act as a management Representative and Person Responsible for Regulatory Compliance (PRRC) for BWI US Sites according to 100753348.
• Quality Systems – Designated Management Representative for BWI.
• Partners with business and functional leaders to drive risk mitigation, proactive action and continuous improvement. Communicates and promotes Quality vision and goals.
• Recruits and retain high caliber Quality professionals.
• Perform other work-related duties as assigned by the manager of this role
• Responsible for communicating business related issues or opportunities to next management level
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Performs other duties assigned as needed

QUALIFICATIONS

• Bachelor’s degree in Life Sciences or Engineering. A master’s degree is preferred.
• 12+ years of regulated device experience, with a minimum of 5 years in quality management or related functions.
• Experience with cardiac electrophysiology devices preferred.
• Excellent communication skills, both written and oral are required.
• Knowledge of relevant applicable standards and regulations for products and quality systems. Ability to interpret above standards and regulations and apply as an input to all company activities and management decisions.
• Ability to enroll and influence across functional areas is required.
• Strong collaboration and influence management skills to partner effectively with Sector functions and across Operating Units.
• Proven track record of demonstrating collaboration across the organization and at all levels
• Balanced technical understanding of products and processes combined with superior business and compliance acumen.