Quality Engineer I

Johnson & Johnson Innovative Medicine • Warsaw, IN

1d • Onsite

About The Position

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 jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. 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 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/. Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes. Johnson & Johnson MedTech Orthopedics (a member of Johnson & Johnson Family of Companies), is currently seeking a Quality Engineer II to join our outstanding team located in Warsaw, Indiana! The Quality Engineer I position will apply basic Quality Engineering/Scientific Method techniques and principles to daily tasks and activities under general supervision. Individual applies relevant regulations, standards, and industry guidelines to assignments. Individuals work with experienced Quality Engineers to ensure efficient and effective quality & compliance and continuous improvement in our end-to-end business with a focus on manufacturing operations. This role supports new product introduction, continuous improvement initiatives, and base business products and processes (risk management, nonconformances, inspection methods, etc.)

Requirements

• Bachelor's Degree in Engineering or equivalent technical/scientific field.
• 0 – 2 years experience in a GMP and/or ISO regulated industry and experience with FDA regulated environment.
• Introductory knowledge of Quality Engineering/Scientific methods and techniques.
• Ability to proficiently communicate both verbal and written in English.

Nice To Haves

• Introductory understanding of manufacturing and inspection equipment and processes.
• Knowledge of statistical techniques and/or software packages and the ability to support analysis.
• Experience with project management and demonstrating organizational skills.
• Critical thinking and attention to detail.
• Strong verbal communication and technical writing.
• Capacity to perform "hands on" problem solving.

Responsibilities

• Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, GxP, and other applicable regulatory requirements
• Support resolution of Quality Issues.
• Owns and supports investigation, bounding, actions, reviews, and approval of non-conformances, CAPAs, and audit findings.
• Support quality system metrics, risk analysis, process controls and process improvements.
• Support execution of validation activities and inspection methods.
• Handle conflict resolution as it relates to technical situations.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees