Staff Quality Engineer, NPD & Validation Leader

Johnson Johnson; Irvine (CA); On-site; USD 110,000 - 160,000; Full time

Job summary

Johnson & Johnson Irvine seeks a Staff Quality Engineer to lead QA activities across the product lifecycle, supporting NPD and design verification. You will apply Six Sigma, SPC and DOE tools, drive risk management, and ensure compliance with MDR and company policies.

You will mentor engineers, coordinate cross-functional teams, and develop robust QC plans, test protocols, and validation reports to ensure high-quality medical products.

Qualifications

• Experience in Quality Engineering within product development and lifecycle management.
• Experience collaborating with cross-functional teams on new product development.

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 with quality improvement opportunities as appropriate to legacy products, continuous improvement and customer satisfaction.
• Oversight, from a Quality NPD perspective, of the 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.). Performs statistical analysis of data generated including but not limited to: Gauge R&R, ANOVA, Sample Size determination and variable/attribute data analysis against predetermined acceptance criteria.
• Support sterility, biocompatibility and packaging test requirements following company standard operation procedures for new products.
• Ensure that development activities follow design control requirements (Design Trace Matrix), product is tested per applicable standards, GSPR are met per the MDR, and product is properly transferred to manufacturing per applicable specifications.
• Technical problem solving, failure analysis, and root cause determination.
• Makes decisions independently on engineering problems and methods and represents the organization in conferences to resolve important questions and to plan and coordinate work.
• Recommend issue resolution to management for significant capability and compliance issues.
• Works closely with functional leadership in planning and executing project milestones.
• Plans, develops, coordinates, and directs one or more large important engineering projects or a number of small projects with many complex features.
• Carries out complex or novel assignments requiring the development of new or improved techniques or procedures.
• Assesses the feasibility and soundness of proposed engineering evaluation tests, products or equipment when necessary, data are insuffic

Skills

Quality Engineering

Six Sigma

SPC

DOE

Gauge R&R

ANOVA

Tools

Quality Tools

Gage R&R

Statistical Methods

Job description

Johnson & Johnson Irvine seeks a Staff Quality Engineer to lead QA activities across the product lifecycle, supporting NPD and design verification. You will apply Six Sigma, SPC and DOE tools, drive risk management, and ensure compliance with MDR and company policies.

You will mentor engineers, coordinate cross-functional teams, and develop robust QC plans, test protocols, and validation reports to ensure high-quality medical products.