Senior Supplier Quality Development Manager
Irvine , California
February 08, 2017

Ethicon, a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Supplier Quality Development Manager in the new Supplier Quality Development Engineering Organization, which can be located at any Ethicon or CSS R&D location, targeting Somerville, NJ, Cincinnati, OH, Irvine, CA and Irwindale, CA.

The team will partner with the Product Management and Advanced Sourcing & Innovation teams throughout both the development & qualification processes as well as the development of the supplier’s quality systems.  This team will be organized by category and leveraged across ETH/CSS similar to the Product Management Engineering organization.  Key areas where this team will partner with AS&I and Product Mgmt are supplier selection, CTQ cascade, component development, test method verification, and component qualification.  There are 1,000+ components currently being developed across the ETH/CSS supply chain and this will require the team to take a risk-based approach to focus on key suppliers and components.  

The Supplier Quality Engineering Manager is responsible for:
Managing, implementing & monitoring supplier development at external sites for manufacture of finished devices, sub-assemblies & components
Managing design, implementing & monitoring of quality systems at external sites for manufacture of finished devices, sub-assemblies & components

Manage daily operations, budget, and personnel activities for supplier quality development engineering team
Lead team with a strategic focus that includes needs of all applicable ETHICON-CSS sites and new product development projects.
Act as liaison to applicable ETHICON-CSS sites & Suppliers ensuring that consistency exists between those sites, suppliers & corporate.
Plan & implement document creation, retention, format & distribution programs meeting all regulatory (e.g., GMP, ISO) & quality requirements
Establish clear processes & procedures for the Supplier Quality Development Engineering organization influencing and leveraging across ETHICON-CSS Operating Companies.
Act as primary interface regarding supplier & documentation issues in all audits related to new product launches, including internal, GMP & ISO
Communicate requirements, services & programs to associates 
Oversee training programs to improve effectiveness & efficiency of group 
Support & encourage development of team members
Facilitate development of process to identify customer needs, appropriate measurement criteria for team to meet these needs & aid team in developing programs to respond to these needs
Assure that component suppliers & external manufacturers have strong, capable quality systems & are in compliance with government & corporate regulations 
Provide leadership to external manufacturing & component supplier quality systems regarding strategic & tactical direction
Other responsibilities may be assigned & not all responsibilities listed may be assigned
SUPERVISORY RESPONSIBILITIES: Manage team with occasional additional responsibility for temporary associates
TRAVEL REQUIREMENTS: Moderate to heavy travel may be required

A minimum of a BS Degree in engineering or applied science or equivalent, required.  
CQE (Quality Engineer Certification), CQA (Quality Auditor Certification), CQM (Quality Manager Certification) preferred
A minimum of 3+ years’ experience in a Supply Chain environment, preferred.
A minimum of 2+ years’ experience with Supplier Quality Systems in an FDA (Food & Drug Administration)-regulated environment preferred
A minimum of 9+ years’ minimum combined experience with experience in quality or quality engineering roles. requirements
Working knowledge of GMP (Good Manufacturing Practices - preferably medical device), ISO (International Organization for Standardization) & MDD (Medical Devices Directive) requirements, preferred 
Interpersonal skills- develop relationships with internal and external customers
Prioritize–set priorities & understand limitations 
Selective - programs & processes to meet regulatory & corporate business needs
Reasoning ability - distinguishing between necessary & desirable qualities of programs
Able to understand processes & procedures for documentation 
Institutive - innovative approaches to Quality System's applications & efficiencies
Strategic - to activities & ability to translate concepts or regulations into concrete programs
Motivational - people of diverse technical & non-technical backgrounds
Working knowledge of Lean, Operational Excellence, Six Sigma (Black Belt or Green Belt)

BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies. 


Primary Location
United States-Ohio-Cincinnati
Other Locations
North America-United States-California-Irwindale, North America-United States-California-Irvine, North America-United States-New Jersey-Somerville
Ethicon Endo Surgery Inc (6041)
Job Function
Quality (Eng)

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