J&J Family of Companies SR QUALITY ENGINEER in Warsaw, Indiana
At Johnson & Johnson we value talented, passionate and committed professionals. And we know sometimes those professionals leave the industry for a while. So, if you’re a skilled technical leader who wants to get back up to speed and make your mark, our Re-Ignite Program is just what you are looking for. Re-Ignite has been carefully designed to help you build your capabilities, enhance your leadership skills and continue your professional journey. The program consists of a four-month assignment within Johnson & Johnson and will provide a direct opportunity to apply for full-time roles after successfully completing the program.
This program is part of a large initiative to increase the WiSTEM2D (Science, Technology, Engineering, Math, Manufacturing & Design) talent pipeline inspired by the Society of Women Engineers and iRelaunch, a career re-entry firm.
Medical Devices & Diagnostics Global Services, LLC., represents more than 60 manufacturing sites and 26,000 employees who plan, source, manufacture and deliver high-quality and cost-effective medical products to our customers around the globe each day. Work of the MD&D Supply Chain supports a multitude of product platforms, new products and delivery systems that are used in a wide range of procedures throughout the healthcare industry, including interventional cardiology, electrophysiology, minimally invasive surgery, hospital sterilization, clinical laboratory testing, diabetes management, joint replacement surgery and vision care.
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.
You will plan, conduct and direct engineering projects or studies including complete projects requiring advanced knowledge of a specialized field. They apply comprehensive and diverse knowledge of engineering principles and practices within broad assignment areas. They may oversee and direct activities of technical support staff and are responsible for technical development of assigned staff.
The Senior 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. You 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. 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 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.
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.
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.
Production/Process Controls including Control Plans
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; 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.
- 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
At least a 2 year break from engineering (or other STEM field) required.
A minimum of a Bachelor’s Degree, preferably in Engineering or related technical field. Requires 6 years related experience.
You should have worked in both an FDA and European regulatory environment.
This position will require meaningful experience working in manufacturing/operations.
In-depth knowledge of product/process Risk Management (FDA and ISO standards) is required.
The ability to perform "hands on" troubleshooting and problem solving is helpful. Good technical understanding of manufacturing equipment and processes is helpful.
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 helpful.
Validated project management, Technical Writing, Change Management Techniques and project leadership abilities will be helpful.
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)