Director, Source Quality

Company: Disability Solutions
Location: Irvine
Posted on: September 18, 2023

Job Description:

Biosense Webster, part of Johnson & Johnson Family of Companies, is recruiting a Director, Source Quality to be located at Irvine, CA. At Biosense Webster, Inc. we have one goal - to ensure those with cardiac arrhythmias can live the lives they want. This means transforming the latest advancements in electrophysiology into a suite of tools that empowers physicians with a range of treatments for the best outcomes. Quality products and approaches are achievable only through collaboration with the smartest minds in electrophysiology. For more than 30 years, we've been the global market leader in the science and technology of cardiac arrhythmia treatment, working with thousands of electrophysiologists to identify and develop diagnostic and treatment tools. And through onsite training, online courses and our global education centers, we work together to set new standards every day. Learn more about Biosense Webster at www.biosensewebster.com and follow us on LinkedIn. The Director of Source Quality is responsible for ensuring that supplier-related processes are robust, compliant and align with company's strategic priorities, while driving needed improvements in performance across the supply base. This position has the responsibilities across Cardiovascular and Specialty Solution (CSS) Companies Johnson and Johnson Family of Companies including a span of multiple product platforms such as General Surgical Devices, ENT, Electrophysiology and Surgical and Non-Surgical Aesthetics. Are you interested in joining a diverse team delivering outstanding results to our customers? Apply now for this exciting opportunity! Key Responsibilities:

• Responsible for the planning and execution of external Quality Management System.
• Ensures the development and implementation of global external supply quality systems policies and strategies that align with the company business, and MD Supply Chain Quality and Compliance strategies, and global regulatory requirements.
• Apply knowledge of regulations, policies and application, auditing techniques (internal and external entities), gap analysis and risk management.
• Apply operations process knowledge relating to product quality and process performance.
• Develop component supplier and external manufacturing quality and compliance capabilities to deliver value to the business and the MD Supply Chain.
• Implement and improves systems, policies and procedures for the identification, estimation, evaluation and reduction of risk associated with our products and services.
• Establish and monitor metrics to ensure value is delivered to the business.
• Provide active link and partnership between the supplier and external manufacturing sites and franchise headquarters.
• Lead the Quality Management Review process and CAPA process related to suppliers and externally manufactured products.
• Reviews and approves changes that may impact product quality.
• Plans the quality and compliance assessments of external manufacturing plants and component suppliers.

Keywords: Disability Solutions, Irvine , Director, Source Quality, Executive , Irvine, California