Quality Engineer II

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

Job Function:
Supply Chain Engineering

Job Sub Function:
Quality Engineering

Job Category:
Scientific/Technology

All Job Posting Locations:
Warsaw, Indiana, United States of America

Job Description:

Johnson & Johnson MedTech Orthopedics (a member of the Johnson & Johnson Family of Companies) is currently seeking a Quality Engineer II to join our outstanding team located in Warsaw, Indiana.

About MedTech

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness.

Learn more at https://www.jnj.com/medtech

The Quality Engineer II position will apply leadership, interdependent partnering, and Quality Engineering expertise to ensure efficient and effective quality & compliance and continuous improvement in our end-to-end business with a focus in manufacturing operations.

They will also apply these principles and problem-solving skills to develop and optimize products & processes that are aligned with the overall business vision.

This individual will support process containment and bounding of nonconforming product.

They also apply appropriate risk management to prevent unanticipated failure modes and improve capability of processes.  They pioneer methods and techniques to be used or adapt standard methods to meet needs.

They coordinate phases of work internally and externally and may direct activities of technical support staff.

This role supports new product introduction, continuous improvement initiatives, and base business products and processes.

Key Responsibilities:


* Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, GxP, and other applicable regulatory requirements


* Identifying and supporting resolution of Quality Issues.  Owns and supports investigation, bounding, actions, reviews, and approval of non-conformances, CAPAs, and audit findings.


* Developing, tracking, and reporting quality metrics to improve Quality Systems.


* Conduct risk-based decision making and create and update risk documentation and manufacturing control plans.


* Use lean principles to make process improvements.


* Perform validation activities and support NPI projects as part of design transfer.


* Handle conflict resolution as it relates to technical situations.


* Coaching other...