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
KEY JOB RESPONSIBILITIES:
• 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 requiredQualifications
• 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)
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J2W: LI NAPrimary Location
United States-Ohio-CincinnatiOther Locations
North America-United States-California-Irwindale, North America-United States-California-Irvine, North America-United States-New Jersey-SomervilleOrganization
Ethicon Endo Surgery Inc (6041)Job Function
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