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
- \r
- 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.
- \r
- 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
- \r
- 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 Quinta , Senior Director, Supply Chain Quality- Electrophysiology (EP), Professions , Irvine, California
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