Johnson & Johnson Careers
Value Stream Quality Engineer
Requisition ID: 0679180826
DePuy Synthes Companies of Johnson & Johnson is seeking a Value Stream Quality Engineer based in Warsaw, IN.
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies 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. Building on the legacy and strengths of two great companies, more agile and better equipped to meet the needs of today’s evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.
The Value Stream Quality Engineer conducts assignments encompassing complete projects or portions of major projects. They determine methods and techniques to be used or adapt standard methods to meet variations. They coordinate phases of work internally and externally.
The Value Stream Quality 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 Value Stream Base Business processes/products including Final Clean & Pack (Clean Room Environment) and Sterilization Operations.
Major Responsibilities & Duties:
- Support quality and business continuous improvement initiatives to deliver on business strategic Key Performance Indicators. Responsibilities includes Final Clean & Pack (Clean Room Environment) and product Sterilization.
- 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
- 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 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.
- 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 (CSV), pFMEA, Trace Matrixes, Inspection Plans, Cleaning Validations, etc.
- A minimum of a Bachelor’s Degree, preferably in Engineering or related technical field.
- A minimum of 2 years of related experience is required.
- Experience working in both an FDA and European regulatory environment is preferred.
- This position will require relevant experience working in manufacturing/operations.
- In-depth knowledge of product/process Risk Management (FDA and ISO standards) is required.
- Experience with a proven track record of implementing appropriate risk mitigation.
- 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, Process & Computer System Validation expertise is preferred.
- A thorough understanding of GMP/ISO regulations and validation regulations is preferred.
- Demonstrated project management, Technical Writing, Change Management Techniques and project leadership abilities are preferred.
- Clean room Quality Control operations, Sterilization and Cleaning Validation previous experience is preferred.
This position may require up to 10% travel and will be based in Warsaw, IN.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Depuy Orthopaedics. Inc. (6029)