Johnson & Johnson is seeking a Senior Quality Engineer to ensure effective product quality processes are in place and executed throughout the lifecycle of products, particularly in the development of next-generation medical devices.
Requirements
- A minimum of 4 years of quality, manufacturing, or research and development experience in a medical device or other regulated industry
- Ability to define problems, collect and analyze data, establish facts, and draw conclusions and recommendations
- Ability to use broad knowledge of regulatory, technical, and business requirements to conduct due diligence assessments
- Knowledge of groundbreaking Quality Engineering, design control, and verification and validation (V&V) tools and methodologies
- Understanding of theoretical and practical fundamentals and experimental engineering techniques such as DOE, DMAIC and ANOVA.
- Six Sigma/ Design for Six Sigma experience, and/or knowledge of Process Excellence tools
- Lean manufacturing experience
Responsibilities
- Working with other functional groups, including R&D and Operations in support of new product development, engineering projects, quality assurance activities, and lifecycle management.
- Using Quality Engineering tools/processes in development and implementation of practices for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle.
- Oversight, from a Quality NPD perspective, of the Non-Conformance Report (NCR) process for BWI facilities located in the U.S.
- Develop and establish effective quality control and support associated risk management plans, AFMEA, DFMEA and PFMEA.
- Write, review and/or approve process and product validation protocols and reports, equipment qualifications, engineering change orders.
- Use statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, Statistical Process Control (SPC), Design of Experiments (DOE), etc.).
- Ensure that development activities follow design control requirements (Design Trace Matrix), product is tested per applicable standards, GSPR are met per the MDR, and product is accurately transferred to manufacturing per applicable specifications.
Other
- A minimum of a Bachelor’s degree, required; preferably in engineering and/or scientific field
- Ability to travel up to 20% for local, domestic or international business support is required
- Ability to communicate business related issues or opportunities to next management level
- Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
- Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
