Johnson & Johnson Careers
Senior Quality Engineer, Change Control
Requisition ID: 7033190207
DePuy Synthes is hiring a Senior Quality Engineer, Change Control, in the Warsaw, IN area.
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopedic and neurological business in the world. DePuy Synthes Companies will offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials.
The Sr. Quality Engineer, Change Control, plans, conducts and directs engineering projects or studies including complete projects requiring advanced knowledge of a specialized field. The Engineer will lead, coach and mentor in area of Change Control Management for the Warsaw, IN Supply Chain. They apply comprehensive and diverse knowledge of engineering principles and practices within broad assignment areas. They may coordinate and direct activities of technical support staff and are responsible for technical development of assigned staff.
• 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.
• Will also utilize Quality Engineering principles and analytical skills to improve and maintain products/processes that are aligned with the overall Quality and Business vision.
• Will utilize appropriate risk management to prevent unanticipated failure modes and improve capability of processes.
• Will support change control & continuous improvement initiatives and product/processes in base business as required.
• Support quality and business continuous improvement initiatives to deliver on business strategic Key Performance Indicators.
• Support PDCA, Six Sigma, Kaizen, Lean Techniques, DIR, CRRM, JJPS and/or other improvement programs.
• Conduct benchmarking and network 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.
• 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 new product introduction as part of design transfer.
• 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 needed.
• 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
• Assume the Role & Responsibility of the Quality function on Process Validations or Verifications. It can include both not limited: Collaborate/Review/Approve IQ, OQ, PQ, TMV or Software Validation, pFMEA, Trace Matrixes, Inspection Plans, etc.
• Partners with J&J Global Supply chain, Finished Goods and material suppliers to ensure appropriate application of Process & Computer Systems 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, support, review or analyze whether a proposed change to a process will not improve 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 built 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 required.
• 5 years related quality engineering experience required.
• Experience with Change Control Management in a manufacturing/production setting required.
• Relevant experience working in manufacturing/operations setting required.
• In-depth knowledge of product/process Risk Management (FDA and ISO standards) is required.
• Experience implementing appropriate risk mitigation required.
• Technical training and/or experience using Statistics, Lean and Six Sigma Methodologies is preferred including Measurement System Analysis, SPC, DOEs, Reliability, etc required.
• Good technical understanding of manufacturing equipment and processes is required.
• Advanced knowledge and experience in the areas listed in the duties required.
• 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.
• Understanding of the NPI (New Product Introduction) process, Process Validation and Computer Systems Validations (CSV) expertise is preferred.
• A thorough understanding of GMP/ISO regulations and validation regulations is preferred.
• Experience working in both an FDA and European regulatory environment is preferred.
• Demonstrated project management, Technical Writing, Change Management Techniques and project leadership abilities are preferred.
• Experience working in the medical device industry preferred.
• This position may require up to 10% travel.
Depuy Orthopaedics. Inc. (6029)