Johnson & Johnson Careers
Senior NPI & CI Quality Engineer
Requisition ID: 8838180805
DePuy Synthes Companies of Johnson & Johnson is seeking a Senior NPI & CI 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 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. Building on the legacy and strengths of two great companies, we are creating one organization that will be agile and better equipped in 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 Senior NPI & CI Quality 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.
In this role, you will utilize Quality Engineering tools and practices for the effective and efficient development, transfer and maintenance of products/processes throughout the product lifecycle. You will also utilize Quality Engineering principles and analytical skills to improve and maintain products/processes that align 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.
Major Responsibilities & Duties:
- Support business and quality 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.
- 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
- Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.
- 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, etc.
Production/Process Controls including Control Plans
- Develop, interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk.
- 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.
- A minimum of a Bachelor’s Degree is required, preferably in Engineering or related technical field.
- A minimum of 5 years of related experience is required.
- Experience working in both an FDA and European regulatory environment is preferred.
- Relevant experience working in manufacturing/operations is required.
- Good technical understanding of manufacturing equipment and processes is required.
- In-depth knowledge of product/process Risk Management (FDA and ISO standards) is required.
- Experience with a consistent track record of implementing appropriate 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 with the ability to preview, graph, analyze, and present data in a way that facilitates/drives decision-making is preferred.
- The ability to perform "hands on" troubleshooting and problem solving is preferred. The ability to think on your feet and providing good judgment is highly desired.
- Understanding of the NPI (New Product Introduction) process and Process & Computer System Validation expertise is preferred.
- A deep understanding of GMP/ISO and validation regulations is preferred.
- Demonstrated project management, technical writing, change management, and project leadership abilities are preferred.
This position will be based in Warsaw, IN and may require up to 10% domestic/international travel.
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)