Johnson & Johnson is seeking a Quality Engineer 1 NPD to ensure effective product quality processes are in place and executed throughout the lifecycle of a product, particularly for new product development (NPD). This role will contribute to developing products, designing verification tests, process validations, and quality processes to ensure compliance with company and external standards, aiming to deliver innovative healthcare solutions.
Requirements
- Ability to define problems, collect and analyze data, establish facts, and draw conclusions and recommendations
- Ability to develop and implement Quality standards
- Demonstrated auditing and problem-solving skills
- Knowledge of leading-edge Quality Engineering, design control, and verification and validation (V&V) tools and methodologies is a plus.
- Understanding of theoretical and practical fundamentals and experimental engineering techniques such as DOE, DMAIC and ANOVA is a plus.
- Working knowledge of SolidWorks, other CAD based programs (ie. basic dimensioning, tolerance stack analysis) is a plus.
- Experience with Minitab, R and other statistical software is a plus.
Responsibilities
- executes quality assurance activities intended to ensure effective product quality processes are in place and executed throughout the lifecycle of a product.
- Involved in NPD teams and other activities to develop products, design verification tests, process validations and quality processes to ensure compliance with the company’s Quality System policies and procedures and applicable external requirements and standards.
- assists in developing quality-engineered systems and products, and support qualification and validation activities.
- contribute to activities including risk management document development, creation, and design of catheter test methods, authoring of test protocols, and testing of products during their development cycle.
- 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.
- 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.
Other
- Bachelor’s degree, required; preferably in engineering and/or scientific discipline
- 0- 2 years of quality, manufacturing, or research and development experience in a medical device or other regulated industry
- Ability to effectively collaborate and communicate with internal and external partners at all levels of the organization.
- This position may require up to 20% of domestic and/or international travel.
- Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law.
