Senior NPD Quality Engineer – MedTech

Johnson & Johnson Co.; Irvine (CA); On-site; USD 79,000 - 128,000; Full time

Benefits offered by this job

Pension plan

401(k) savings

Vacation 120 hours

Holidays 13 days

Parental leave

Job summary

Johnson & Johnson in Irvine, CA is seeking a Senior Quality Engineer to plan, coordinate and execute quality assurance activities throughout the product lifecycle. You will support New Product Development teams, develop test methods, and ensure compliance with Quality System policies and MDR.

You will lead risk management, participate in design control, and mentor other engineers while applying Six Sigma, DOE, and SPC to improve process capability.

Qualifications

• Ability to define problems, collect and analyze data, establish facts, and draw conclusions.
• Ability to apply project management skills to ensure fulfillment of new product development requirements.
• Knowledge of regulatory, technical, and business requirements to conduct due diligence assessments.
• Auditing and problem-solving skills.
• Knowledge of DOE, DMAIC, ANOVA.

Responsibilities

• Support NPD teams with quality assurance across product lifecycle.
• Lead quality control and risk management plans and related analyses.
• Write, review and approve validation protocols and reports.
• Use statistical tools to analyze data and improve process capability.
• Collaborate with the Design Team on tests and protocols.

Skills

Six Sigma

Lean

GMP

CAD

GD&T

DOE

ANOVA

Minitab

R

Education

Bachelor's degree

Tools

SolidWorks

AutoCAD

Minitab

R

Job description

Johnson & Johnson in Irvine, CA is seeking a Senior Quality Engineer to plan, coordinate and execute quality assurance activities throughout the product lifecycle. You will support New Product Development teams, develop test methods, and ensure compliance with Quality System policies and MDR.

You will lead risk management, participate in design control, and mentor other engineers while applying Six Sigma, DOE, and SPC to improve process capability.