Ethicon, a member of Johnson & Johnson's Family of Companies, is recruiting for a Staff Supplier Quality Engineer 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 Staff Supplier Quality Development Engineer primary function includes but is not limited to:
• Component development as part of New Product or Process Introduction.
• Selection of suppliers for highly engineered components.
• Implementation of Critical to Quality requirements for externally manufactured components ensuring robust processes at suppliers that meet CTQ’s.
• Qualification of highly engineered components including validation, requirements review, risk management such as FMEA’s and Control plans, Test Method validation and measurement system analysis, Development of inspection strategies.
• Demonstrating strong proficiency in applying established tools and methods (for example, Six Sigma, Lean) to identify and realize new product or process introductions, as well as process and business improvements.
• Leading and/or contributing to the utilization of various risk management and risk mitigation tools and practices (for example, mistake proofing, critical control points, failure mode and effects analysis).
• Leading or contributing to the reliability assessments of product design.
• Leading and/or contributing to root cause investigations using various problem solving techniques and tools (Ex. K-T analysis), and assesses effectiveness of corrective actions.
• Conducting and supporting the development of, test methods in equipment, process, and product qualifications/validations.
• Developing, implementing, and/or maintaining process Quality control plans that are in accordance with product or process risk level, and ensures those plans are consistently followed.
• Developing, implementing, and/or maintaining production and process controls using appropriate techniques and tools (for example, advanced process monitoring and control tools, methods of statistical process control, process performance metrics). Perform or guide Measurement Systems Analysis (MSA).
• Mentoring others in various technical capabilities.
• Interpreting standard and non-standard sampling plans.
• Participating in technical reviews as appropriate.
• Supporting execution of strategic vision or plan by collaborating with other quality leaders to identify required Quality Engineering skills and competencies.
Supports the application of quality engineering and quality compliance in support of demanding projects.
May also be involved with Quality Systems initiatives as a primary assignment or additional assignment.
Will have more advanced understanding of the expected output of quality processes and be able to assess the adequacy of objective evidence.
Will be able to take more complex CAPA issues and drive to completion.
Plan and perform basic reliability testing and analysis.
Experience managing projects and demonstrating project leadership abilities.
A minimum of BS in engineering from an accredited engineering or relevant science is required.
A relevant advanced degree is preferred.
A minimum of 6 years of work experience is expected.
Experience in a regulated industry (medical device, biopharmaceutical, or pharmaceutical).
Applies advanced Quality Engineering/Scientific Method techniques and principles to daily tasks and activities. In addition, applies relevant regulations, standards, GxP requirements, and industry best practices to assignments.
Plans and conducts projects with moderate to high technical responsibility, complexity, or strategic input.
Receives summary instructions from technical Quality leaders at various levels, in addition to other functional stakeholders.
Black Belt in one or more of the Process Excellence roadmaps (DMADVV, DMAIIC, or Lean). preferred
Certifications - Certified Quality Engineer from ASQ and additional certifications are preferred.
Advanced knowledge of Quality Engineering/Scientific Method techniques and principles. Applied statistics of increasing complexity
Strong technical understanding of manufacturing equipment and processes.
Understanding of new product or process introduction processes, and expertise in component qualifications/process validations.
Experience implementing appropriate risk mitigation with knowledge of product or process and process Risk Management (FDA & ISO standards).
Experience working in a regulated environment. This includes knowledge of, and experience with, applicable standards, GxP requirements and regulations.
• Design control
• Good documentation practices
• Good manufacturing practices
• Organizational requirements
• Root cause analysis and Corrective Action / Preventive Action (CAPA) expectations -
Staff Quality Engineer will be called to mentor less experienced quality engineers. At times the Staff QE may be required to supervise external contractors.
Up to 50% travel required in support of projects at multiple Operating Companies. At times may require more travel.