Johnson & Johnson is looking to ensure effective product quality processes are in place and executed throughout the lifecycle of products, particularly in the context of New Product Development (NPD). This involves developing products, designing verification tests, process validations, and quality processes to ensure compliance with internal Quality System policies and external requirements and standards.
Requirements
- Ability to define problems, collect and analyze data, establish facts, and draw conclusions and recommendations
- Ability to develop and implement Quality standards
- 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.
- Six Sigma/ Design for Six Sigma experience, and/or knowledge of Process Excellence tools
- Lean manufacturing experience
- Knowledge of Quality and operations systems and processes, including GMP
Responsibilities
- Plans, coordinates and executes quality assurance activities intended to ensure effective product quality processes are in place and executed throughout lifecycle of product.
- Involved in New Product Development (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 to develop 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
- Minimum of 4 years of quality, manufacturing, or research and development experience (required) in a medical device or other regulated industry (preferred)
- Ability to use broad knowledge of regulatory, technical, and business requirements to conduct due diligence assessments
- Ability to apply project management skills to ensure fulfillment of new product development requirements
- Demonstrated auditing and problem-solving skills
