Senior Quality Engineer, NPD Leader - Medical Devices

jj; Irvine (CA); Presencial; USD 79 000 - 128 000; Tempo integral

Resumo da oferta

Johnson & Johnson in Irvine, California is seeking a Senior Quality Engineer to plan and execute quality assurance activities across the product lifecycle, supporting New Product Development teams with design verification, process validation and quality system compliance.

You will lead quality engineering initiatives, apply Six Sigma, SPC and DOE methods, collaborate with R&D and Operations, and mentor other engineers while ensuring GSPR, design controls and risk management are integrated

Qualificações

• Ability to define problems, collect and analyze data, establish facts, and draw conclusions and recommendations.
• 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.
• Knowledge of leading-edge Quality Engineering, design control, and verification/validation tools and methodologies.
• Lean manufacturing experience and GMP familiarity.

Responsabilidades

• Collaborate with R&D and Operations on NPD and lifecycle management.
• Apply quality engineering tools for development, transfer and maintenance of products/processes.
• Oversee NCR process from a Quality NPD perspective for U.S. facilities.
• Develop and establish effective quality control and risk management plans (AFMEA, DFMEA, PFMEA).
• Write, review and approve validation protocols, equipment qualifications, and change orders.
• Utilize statistical tools (Six Sigma, SPC, DOE) and perform data analysis to drive decisions.

Conhecimentos

Analytical reasoning

Quality systems

Regulatory knowledge

Project management

Leadership

Formação académica

Bachelor’s degree in Engineering or Science

Ferramentas

SolidWorks

AutoCAD

Minitab

R

Gage R&R

Descrição da oferta de emprego

Johnson & Johnson in Irvine, California is seeking a Senior Quality Engineer to plan and execute quality assurance activities across the product lifecycle, supporting New Product Development teams with design verification, process validation and quality system compliance.

You will lead quality engineering initiatives, apply Six Sigma, SPC and DOE methods, collaborate with R&D and Operations, and mentor other engineers while ensuring GSPR, design controls and risk management are integrated