What are the responsibilities and job description for the Senior Quality Engineer position at Johnson & Johnson?
Johnson & Johnson MedTech Orthopedics (a member of Johnson & Johnson Family of Companies) is currently seeking a Senior Quality Engineer to join our outstanding team located in Warsaw, Indiana!
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/.
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.
We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.
At Johnson & Johnson, we all belong.
The Senior Quality Engineer 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 apply these principles and problem-solving skills to develop and optimize products & processes that are aligned with the overall business vision. This individual will lead process containment and bounding of nonconforming product. They 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, mentor more junior engineers, and may coordinate 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 others on quality event investigation processes
