Senior Director, Supply Chain Quality- Electrophysiology (EP)

Company: Disability Solutions
Location: Irvine
Posted on: October 19, 2024

Job Description:

Biosense Webster Inc. is recruiting for a Senior Director, Supply Chain Quality- Electrophysiology (EP) to be located in Irvine, CA, El Paso, TX, or Irving, TX. Other Johnson and Johnson MedTech sites in the United States will also be considered.\rAt 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/.\rFor more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.\rThe Senior Director, Supply Chain Quality - Electrophysiology (EP) is responsible for the Electrophysiology Supply Chain Quality Operations, processes and systems associated with the internal manufacturing sites (Salvarcar, Horizontes) as well as the external suppliers; Indirect, Direct, and External Manufacturers.\rResponsible for driving End to End Supply Chain Quality Execution governance, synergies and optimization across applicable network including development and execution of Operational Excellence Strategy across all sites within the platforms. This role will have overall management responsibilities for both financial and talent including planning for current and future business needs.\rIn addition, the incumbent will develop and execute supplier capability improvement program, working with the J&J MedTech Supply Chain Center of Service (CoS) leaders to ensure initiatives are identified, resourced, completed and measured. He/she will gather data insights and proactive risk measures to identify areas of concern and leverage/execute capability tools/programs to proactively mitigate risk areas to improve Supplier and Strategic Collaborator Reliability.\rResponsibilities:Site(s) Quality Operation

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• Oversees the quality activities for the Cardiovascular Electrophysiology manufacturing facilities. Establishes one Quality Leader with receiving to shipping dock "accountability" including but not limited to; Supply Chain Continuity, Finished Good Product Release, Compliance Readiness Activities, Inspection Execution, Quality System Execution (NC/CAPA/CAPs) and Quality Engineering.
• Partner with Supply Chain to effectively develop and deploy the Supply Chain & Quality strategic plans and assure the integration/alignment of the quality operations strategy at the business level
• Establishes and maintains QS procedures and controls ensuring that performance and quality of the product conforms to established company and regulatory standards.
• Ensures plant(s) assess QS effectively through internal audit and Management review and implement corrective/ preventive, improvement actions as appropriate.
• Oversight and responsibility for complete and correct manufacturing related complaints investigations. Ensures customer feedback and complaints are address in appropriate and timely manner.
• Executes responses to field actions and coordinates global response with the ETE Franchise Quality leadership and corporate functions.
• Champions a Customer Centric Quality culture sustained by the systemic implementation of Lean\rStrategies to Quality Business processes to drive Continuous Improvement and Compliance, while delivering Value Enhancing solutions.
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  • This individual has the necessary independence, authority, and responsibility to initiate action to prevent nonconformities, enact remediation plans, identify and document quality problems, initiate, recommend, provide and verify solutions to quality problems and direct or control further processing and delivery of nonconforming product.
  • Establishes and monitors metrics for the measurement of Quality indicators and Quality Costs to ensure effectiveness and value to the business.\rSource Quality- Indirect, Direct and External Manufacturer
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    • Establish and execute the Quality Strategy for supplier management.
    • Establish, manage, maintain, and continuously improve all Quality activities associated with suppliers.
    • Drive quality performance improvements by developing quality capabilities and developing and implementing quality improvement plans
    • Active participant in the selection, performance management, and disengagement processes
    • Partners with MedTech Supply Chain Quality CoS, Sourcing and Enterprise Source Quality to develop the supply base strategy and to ensure effective management of the suppliers assigned businesses.
    • Partner with Business R&D and Design Quality to ensure new product sourcing and supplier controls are implemented in line with business and J&J requirements.
    • Administer health authority, MD, and J&J policy requirements and standards to ensure the proper balance of business and compliance needs. Manage this balance to optimize continuous compliant growth within supply base.
    • Ensures execution of compliant purchasing controls.
    • Facilitates the resolution of quality issues affecting the compliance and/or supply continuity of goods sourced.
    • Support Regulatory body audits at internal sites and suppliers as required.
    • Provide Supplier Quality Engineering support including inspection technique support, product non-conformances, verification/validation activities, CAPA and change management as required
    • Accountable for tracking and reporting of executed initiatives and associated improvement measures and targets.
    • Identify and lead opportunities for proactive quality including intelligent automation opportunities and quality improvement projects
    • Defining regular reporting and updates to ensure visibility (risks & mitigation, Quality & Compliance KPIs, etc.)\r\r

Keywords: Disability Solutions, La Mesa , Senior Director, Supply Chain Quality- Electrophysiology (EP), Professions , Irvine, California