Sr Design Quality Engineer

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

R&D Product Development

Job Sub Function:

Biomedical Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Shanghai, China

Job Description:

KEY RESPONSIBILITIES/TASKS/ 主要职责/任务

• Provide leadership in design & device implementation to support entire product life cycle of various products with focus on Quality Engineering activities such as reliability, risk management, analytics/statistical techniques, requirements management, verification & validation, and design control.
• Apply tools and methods (for example: Six Sigma, Lean) to realize new product or process introductions as well as process and business improvements.
• Provide leadership and technical expertise to ensure conformance to ISO, FDA & MDR based quality systems.
• Review and approve the release of new products and design changes ensuring quality requirements are met.
• Direct development & consistent application of quality policies & procedures in product design & development, secondary development & transfer operations.
• Act as technical liaison between product development, manufacturing, external manufacturers & suppliers.
• Use analytical problem-solving skills for root cause investigations.
• Use sound statistical applications in areas such as DOE, sampling techniques, regression, reliability, FMEA, hypothesis testing, etc.

 

 

Required Skills:

 

 

Preferred Skills:

Analytical Reasoning, Bioinformatics, Biological Engineering, Biological Sciences, Biostatistics, Coaching, Data Savvy, Detail-Oriented, Feasibility Studies, Inventory Management, Preclinical Research, Project Schedule, Prototyping, Research and Development, Researching, SAP Product Lifecycle Management, Technologically Savvy