QUALITY SOURCE MANAGER (HORIZONTES)

at  Johnson Johnson

At Johnson & Johnson , the largest healthcare company in the world, we come together for one purpose: to transform the history of health in humanity.
Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years. Regardless of your race, belief, sexual orientation, religion, or any other trait, YOU are welcome in all open positions at the largest healthcare company in the world.
When You Join Johnson & Johnson, Your Move Could Mean Our Next Breakthrough .
At Johnson & Johnson Medical Devices Companies , we are using our breadth, scale, and experience to reimagine the way healthcare is delivered and to help people live longer, healthier lives.
In a radically changing environment, we are making connections across science and technology to combine our own expertise in surgery, orthopedics, and interventional solutions with the big ideas of others to design and deliver doctor and patient-centric products and solutions.
We are in this for life .
We are changing the trajectory of human health, YOU CAN TOO .
Please visit https://www.jnjmedicaldevices.com/es-419 for more information.
Biosense Webster, Inc. is recognized worldwide as a leader in the science behind the diagnosis and treatment of cardiac arrhythmias. Guided by the needs of electrophysiologists and cardiologists, Biosense Webster has pioneered innovative technological advancements for more than 30 years. Some might call this quite a heritage. At Biosense Webster, we say it’s just the beginning. For more information, visit www.biosensewebster.com

QUALIFICATIONS

• A minimum a BA/BS degree in Engineering or Life Science is required.
• A minimum of 6 years of experience in a regulated industry is required.
• Supplier Quality or Procurement experience is preferred.
• People management/talent development experience desirable.
• Hands on strategy development and deployment experience is preferred.
• Computer literate in the use of software applications including Microsoft Office (Word, Excel, PowerPoint) is required.
• General Understanding of regulatory compliance requirements (QSR, MDD, ISO 9001, ISO13485, ISO 14971 and other international standards) is required.
• ASQ Certification: Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), Certified Manager of Quality/Organizational Excellence (CMQ/OE), Certified Supplier Quality Professional (CSQP), and/or Certified Six Sigma Black Belt (CSSBB) preferred.
• J&J Flawless Project Execution (FPX) or Project Management Professional (PMP) Certification, and/or J&J Lean/Six Sigma Certification desirable.
• Excellent verbal/written communication and influencing skills required.
• Fluent English mandatory. Spanish, Portuguese, or German desired.
• Proven business acumen. The ability to collaborate with all levels of management in matrixed team environment is preferred.

This role leads/manages the Source Quality Management (SQM)/Purchasing Control process and ensures that Biosense Webster Suppliers provide purchased finished goods, direct and indirect materials or services in compliance with BWI and J&J policies/procedures, Global Regulations and industry standards.

You will be responsible for :

• Serves/provides management oversight for direct reports focusing on Purchasing Controls/Supplier Quality Management for assigned supplier categories globally
• Develops and deploys strategies to effectively manage direct and indirect Suppliers with appropriate risk-based controls
• Collaborates with Procurement on process/product improvement projects and in the implementation of Purchasing Controls
• Analyzes quality data and identifies trends impacting risks/benefits requirements of process, product and quality systems with primary responsibility for the development and maintenance of BWI external suppliers
• Utilizes key knowledge of business processes, analytical tools, and the regulatory environment to support the supplier quality management lifecycle
• Prepares Supplier Quality Agreements at the direction of the Director/Senior Manager
• Leads/assists in the maintenance of the supplier quality relationship (proactive quality reviews, risk-sensing modeling, follow-up on corrective actions, metrics development/improvements, etc.)
• Understands or anticipates the customer’s needs and adds value by providing specific metric information tailored to the particular business environment
• Proactively identifies unmet business needs and takes actions to identify internal/ external customer requirements and translates them into actions with appropriate prioritization and organizational communication
• Responds proactively to emerging industry, regulatory, and business changes
• Compiles and recommends data driven conclusions for Management Review
• Leads/participates in the external supply selection process to provide quality system expertise
• Analyzes quality system trends, identifies issues, and implements appropriate actions
• Participates in franchise-wide assessments and applies risk mitigation strategies to address the regulatory gaps identified in the quality systems for external supply
• Participates in benchmarking and voice of the customer activities and applies learning’s to the external supply quality systems enhancement projects
• Ensures compliance to applicable Global Regulations and standards (e.g. QSR, ISO, EN, Medical Device Directive (MDD), and EU MDR requirements)
• Interfaces with site Supplier Quality Management Leads to deploy tactical responses.
• Responsible for communicating business related issues or opportunities to next management level
• 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