Staff Quality Engineer, New Product Development

J&J MedTech is recruiting for a Staff Quality Engineer, New Product Development , located in Cincinnati, OH or Santa Clara, CA.

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 https://www.jnj.com/ .

In this role you will be responsible for providing quality engineering support and leadership for New Product Development!

This role supports product quality and reliability ensuring the implementation of ground-breaking technology for medical devices is safe, effective, and follows applicable regulations, standards, and industry practices. Working closely with multi-functional teams, this individual will act as a domain authority for product quality throughout the development lifecycle. The individual reviews and assesses development activities (e.g., user needs, development/quality plans, requirements, architecture and design, verification and validation) to ensure that they align with applicable procedures standards and regulatory requirements. Additional responsibilities may include but are not limited to supporting other areas of the Quality Management System such as CAPA, Complaints, post market surveillance and both Internal & External Audits.

Key Responsibilities:

• Launch and stabilize new products through concept, design, development, and steady-state processes.

• Ensures compliance with GMP (Good Manufacturing Practices), ISO (International Organization for Standardization), and all other applicable standards.

• Review and approve design control, manufacturing, quality, engineering, and validation/qualification documents to ensure conformance to business practices and departmental procedures.

• Drive the development of product requirements, verification strategies, and validation strategies.

• Support the Risk Management Process per ISO 14971 by constructing/maintaining a Risk Management file to include design, process, and use FMEAs.

• Develop a reliability strategy and lead reliability testing during new product development.

• Develop inspection and sampling plans for components and finished products.

• 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.

• Proactively engage partners to ensure alignment and resolve issues in a timely manner.

• Technical problem solving, failure analysis, and root cause investigation/determination.