Johnson & Johnson Careers
Manufacturing Quality Engineer (2 openings)
Requisition ID: 6655191003
DePuy Synthes is recruiting a Manufacturing Quality Engineer (2 roles) supporting Joint Reconstruction Manufacturing to be located in Raynham, Massachusetts.
DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies, provides one of the most comprehensive orthopedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com.\
The Engineer conducts assignments encompassing complete projects or portions of major projects. They figure out methods and techniques to be used or adapt standard methods to meet variations. They coordinate phases of work internally and externally.
The Engineer will utilize 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 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 Multi functional partners to ensure the proper application of design controls, risk management and the investigation/correction of design failures/challenges.
• Supports new product introduction as part of design transfer.
Product Quality, Control & Disposition and Performance Standards
• Supports activities related to the 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.
• 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.
• 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
• Ensures effective quality strategies are created for the validation of test methods, process and design.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
• Bachelor's Degree, preferably in Engineering or related technical field
• 3 years relevant experience working in manufacturing/operations setting
• In-depth knowledge of GMP product/process Risk Management (FDA and ISO standards)
• Experience with a consistent track record of implementing appropriate risk mitigation.
• Good technical understanding of manufacturing equipment and processes
• The ability to perform structured troubleshooting and problem-solving
• Language – English
• Ability to travel up to 10%
• Experience working in both an FDA and European regulatory environment
• Strong knowledge of statistical software packages with the ability to preview, graph and analyze data and be able to present data that facilitates/drives decision-making
• The ability to think on the feet and providing sound judgment
• Understanding of the NPI (New Product Introduction) process and Process Validation expertise
• Thorough understanding of GMP/ISO regulations and validation regulations
• Advanced knowledge and experience in the areas listed in the Duties and Responsibilities associated with the position.
• Technical training and experience using Statistics, Lean and Six Sigma Methodologies including Measurement System Analysis, SPC, DOEs, Reliability, etc.
• Demonstrated project management and project leadership abilities
Medical Device Business Services, Inc (6029)