Johnson & Johnson Warsaw , IN 46581
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 driven by the Society of Women Engineers and iRelaunch, a career re-entry firm.
DePuy Synthes Companies of Johnson & Johnson is recruiting for a Senior Customer Quality Engineer in Warsaw, Indiana.
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies offers 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.
This position will support the DePuy Synthes Joint Reconstruction business unit, which offers orthopedic devices and solutions for hip, knee, and shoulder arthroplasty products. The Senior Customer Quality Engineer will lead key projects to improve department capability; improve quality of complaint data and decision making, and achieve Quality System tracked objectives (NC, CAPA, IA), Proactively collaborate and resolve cross-functional issues with stakeholders, and Collaborate with cross-Global Orthopedics companies, MD, and JNJ to identify and implement best, harmonized practices within Customer Quality.
The Senior Customer Quality Engineer will write and approve investigation reports after performing various investigational tasks in accordance with company procedures and quality systems regulations; develop customer correspondence when requested; partner with appropriate functional departments to achieve effective corrective actions and document within the complaint handling system; represent department on post-market surveillance reviews and safety management evaluations; participate on cross-functional and cross-company project teams to help drive consistency and process improvements across the business; interface with key business partners including R&D, Operations, Post Market Surveillance, Quality, Regulatory and Compliance, to insure complete and thorough investigations; serve as subject matter expert for regulatory audits.
The Senior Customer Quality Engineer is responsible for analyzing incoming product complaints, prioritizing investigations based on the event description and risk level, determining appropriate investigation plans and requirements, and partnering cross-functionally to find solutions to customer-reported quality issues.
Bachelor's Degree in Engineering required.
6 Years Experience in an ISO regulated industry and/or GQP/GMP experience required.
2 years away from a STEM related role.
An ability to work cross functionally and promote good working relationships.
The ability to work independently on routine tasks with high attention to detail is required.
The ability to demonstrate sound technical writing and business writing skills is required.
Medical/Pharmaceutical/Health Care Industry Experience is a plus.
Prior Experience with Root Cause Methodologies is preferred.
This role will be based in Warsaw, Indiana and may require up to 10% of domestic travel.
Depuy Orthopaedics. Inc. (6029)