Senior Quality Engineer, NPI & Lifecycle (MedTech)

Biopharma Careers; Irving (TX); On-site; USD 110,000 - 140,000; Full time

Job summary

Johnson & Johnson MedTech in Irving, Texas is seeking a Senior Quality Engineer for New Product Innovation and Lifecycle Management (NPI/LCM) in the Aesthetics & Reconstruction (A&R) organization located in Irving, Texas. Fueled by innovation at the intersection of biology and technology, we’re developing next-gen smarter, less invasive, more personalized treatments.

You will ensure product quality and reliability across the lifecycle, collaborating with multi-functional teams to support NPI and

Qualifications

• A bachelor’s degree in engineering, science, or related technical field from an accredited university.
• Minimum of 5 years of work experience in a regulated industry.
• New product development and lifecycle management experience.
• Prior experience in a Quality Engineering role.
• Knowledge of FDA requirements for design control of medical devices.
• Experience participating in risk management discussions and team-based environments.

Responsibilities

• Support launches and stabilize new product launches through concept, design, development, and steady-state processes.
• Drive development of product requirements, verification strategies, and validation strategies.
• Ensure compliance to GMP, ISO, and applicable standards.
• Provide statistical support and analytical problem solving for product development and manufacturing.
• Review and approve design control, manufacturing, quality, engineering and validation documents.
• Participate in risk management processes and audits; collaborate with cross-functional partners.

Skills

Quality engineering

Regulated industry

Risk management

FDA design controls

Team-based work

Statistical analysis

Education

Bachelor's degree in engineering or science

Advanced degree preferred

Tools

ASQ Certified Quality Engineer

ASQ Certified Reliability Engineer

Green Belt / Lean Six Sigma

Job description

Johnson & Johnson MedTech in Irving, Texas is seeking a Senior Quality Engineer for New Product Innovation and Lifecycle Management (NPI/LCM) in the Aesthetics & Reconstruction (A&R) organization located in Irving, Texas. Fueled by innovation at the intersection of biology and technology, we’re developing next-gen smarter, less invasive, more personalized treatments.

You will ensure product quality and reliability across the lifecycle, collaborating with multi-functional teams to support NPI and