Johnson & Johnson Careers
SENIOR QUALITY ENGINEER
Requisition ID: 1905736132W
"Johnson & Johnson companies are equal opportunity employers"
Ethicon, Inc., a Johnson & Johnson company, is a trusted, world-wide leader in medical devices company who contributes to the advance surgery and improves lives every day. We are qualified as one of the top best place to work. Joining ETHICON is more than joining a great company, it means being a part of a legacy of innovation, development and philanthropy. For more information, visit www.ethicon.com
Searching the best talent for: SR. QUALITY ENGINEER
The Quality Engineer utilizes Quality Engineering tools and practices for the effective and efficient development, transfer and maintenance of products/processes throughout the product lifecycle. The incumbent will also utilize Quality Engineering principles and problem solving skills to improve and maintain products/processes that are aligned with the overall Quality and Business vision. He/she will utilize appropriate risk management to prevent unanticipated failure modes and improve capability of processes. This person will support processes in base business.
• Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
• Review/analyze the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs.
• Conduct benchmarking with external companies or internal sites to develop more effective methods for improving quality
• Supports the development of quality engineering and quality compliance with the right skill sets for new product introductions, and product life cycle management.
• Review/analyze whether current product and processes (including actions or decisions conducted) are in compliance to standards such as the QSRs, ISO 13485, etc.
• Champions compliance to applicable Global Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive (MDD) requirements) including providing support during internal and external audits.
• Conduct periodic line audits to assess for production controls such as lot segregation. Review results of area audits to ensure that corrective and preventive actions are adequate.
New Product/Process Introduction
• Partners with R&D and other cross functional partners to ensure the proper application of design controls, risk management and the investigation/correction of design failures/challenges.
• Supports the development of quality strategies related to the transfer of products, materials and components within J&J or externally. Supports new product introduction as part of design transfer.
• As applicable, Provides supervision, mentoring, coaching, performance review, developmental plans, and succession planning for others
Product Quality, Control & Disposition and Performance Standards
• Lead and maintain Material Review Board.
• Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.
• Accountability and ownership for material identification, material segregation, classification of defect types including the successful application of these techniques on a day-to-day basis in manufacturing.
• Analyze/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process.
• Accountability and ownership of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality
• Approve IQ, OQ, PQ, TMV or Software Validation
Production/Process Controls including Control Plans
Partners with J&J Global Supply chain, Finished Goods and material suppliers to ensure appropriate application of process validation, process control, and risk management; and the investigation/correction of process failures when needed.
Conduct stakeholder analysis to ensure that customer CTQs are known and adequately addressed in control plan
• Develop measurement systems/capabilities, destructive tests, non-destructive tests for manufacturing processes
• Develop control plans consistent with product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc.
• Develop, interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk.
• Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support.
• Develop, interpret and implement standard and non-standard sampling plans
• Assess effectiveness of measurement tools, destructive tests, non-destructive tests, measurement system analysis.
• Accountability and ownership for sampling plans of all types including acceptability of risk given the product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. including assessing, applying and interpreting acceptance sampling standard for manufacturing data.
• Assess and interpret common versus special cause variation in manufacturing processing and determine adequacy of current process limits.
• Document, justify, review or analyze whether a proposed change to a process will not enhance the risk level in some way beyond capability of current controls or whether change will result in potential non-compliance to a required standard such as the QSRs
• Assess the need for risk mitigation techniques given product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. Determine effectiveness of these techniques on previously implemented improvements
• Ownership and accountability of risk assessment process including conducting, documenting, reviewing or maintaining current risk and hazard analysis documentation such as Process FMEAs given product/process changes
• Conduct strategic planning with site leaders and Product Engineering Team. Partnership with other functions to establish business priorities and resource allocation
• Ensures effective quality strategies are created for the validation of test methods, process and design
Reporting to: Quality Operations Manager / Plant Quality Assurance Manager / ** Quality Engineering Manager
EDUCATION AND JOB EXPERIENCE REQUIREMENTS:
• A minimum of a Bachelor’s Degree, preferably in Engineering or related technical field.
• Generally requires 4-6 years related experience.
KEY SKILL / KNOWLEDGE REQUIREMENTS:
• Experience working in both an FDA and European regulatory environment is preferred.
• This position will require relevant experience working in manufacturing/operations.
• Knowledge of product/process Risk Management (FDA and ISO standards) is required.
• Experience with implementation of risk mitigation is preferred.
• Technical training and experience using Statistics, Lean and Six Sigma Methodologies is preferred including Measurement System Analysis, SPC, DOEs, Reliability, etc.
• Strong knowledge of statistical software packages is preferred with the ability to preview, graph and analyze data and be able to present data that facilitates/drives decision making.
• The ability to perform "hands on" troubleshooting and problem solving is preferred. The ability to think on the feet and providing sound judgment is highly desired.
• Good technical understanding of manufacturing equipment and processes is required.
• Understanding of the NPI (New Product Introduction) process and Process Validation expertise is preferred.
• A thorough understanding of GMP/ISO regulations and validation regulations is preferred.
• Knowledge and experience in the areas listed in the Duties and Responsibilities associated with the position.
• Demonstrated project management and project leadership abilities are preferred.
• This position may require up to 30% travel and will be based in an MD&D manufacturing facility.
Global Leadership Profile Competencies
Integrity and Credo-based Actions ~ lives Credo values; builds trust; tells the truth; initiates transparency into problems; demonstrates genuine caring for people
Collaboration and Teaming ~ puts interests of enterprise above own; works well across functions and groups; builds teams effectively; inspires follower ship; instills a global mindset
Results and Performance Driven ~ assumes personal ownership and accountability for business results and solutions; willing to make tough calls; consistently delivers results that meet or exceed expectations; demonstrates a track record of people development; champions diversity; net exporter of successful talent.
Sense of Urgency ~ proactively senses and responds to problems and opportunities; works to reduce "cycle" time; takes action when needed
Mexico-Chihuahua-Juarez-Durango 2751 Colonia Lote Bravo
E.E.S., S.A. de C.V. Mexico (8283)