Johnson & Johnson is seeking a Quality Engineer to support design verification tests, process validations, quality processes, and new product development to ensure compliance with the company's Quality System policies and procedures and applicable external requirements and standards.
Requirements
- A minimum of 2 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
- Ability to develop and implement Quality standards
- Proven auditing and problem-solving skills
- Knowledge of leading-edge 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
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.
- Utilizing 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.
- Leading efforts for continuous quality and customer satisfaction improvement opportunities.
- Support 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.)
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
