Johnson & Johnson MedTech · 1 day ago
Design Quality Engineer Co-Op
Johnson & Johnson MedTech believes health is everything and is focused on healthcare innovation. The Design Quality Engineer Co-Op will support Quality Engineering activities related to Design Controls, Product & Process Validation, Risk Management, and Lifecycle Management for the Wound Closure and Healing Platform.
Hospital & Health Care
Responsibilities
Learns the details of medical device risk management and perform Application & Design Failure Mode and Effect Analysis for existing and new products. Furthermore, also contribute towards the improvement of the combination products program in compliance with 21CFR part 4 (FDA Regulation for combination products)
Assists in various lifecycle management activities including product design changes, complaint trending and analysis, assessment of quality signals, CAPA and remediation activities, and integration of regulations, such as the EU MDR, into the business
Supports the Franchise Technical training program and work to expand it to manufacturing sites. This involves ensuring a robust pipeline of training offerings, managing schedules across time zones, distributing training materials, maintaining digital communications channels, and supporting the Subject Experts with developing content and facilitating their training sessions
Helps plan and execute team building events
Responsible for communicating business related issues or opportunities to next management level
Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable
For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
Performs other duties assigned as needed
Qualification
Required
Enrolled in an accredited college/university
Preferred majors include: Engineering, Life Science, Physical Science, or a related field
Completion of at least freshman year of undergraduate academic program
Availability to work 40 hours/week
Begin understanding and application of core GMP fundamentals, including but not limited to Data Integrity (DI), Good Manufacturing Practices (GMP), and Good Documentation Practices (GDPs)
The Quality Engineer Co-op is expected to begin the accumulation of the following technical quality areas: Design Control, Risk Management, Applied Statistics, Good Documentation Practices, Good Manufacturing Practices
Verbal and written communication skills
Detail oriented, highly organized, and able to manage multiple tasks
Ability to work individually and on a team
Project management, problem solving, and presentation skills
Proficiency in Microsoft Office, Word, PowerPoint, Sharepoint, and Excel
Permanently authorized to work in the U.S., must not require sponsorship of an employment visa (e.g., H-1B or green card) at the time of application or in the future
Preferred
Prior experience in Medical devices or other regulated industries
Demonstrated leadership and/or participation in campus extracurricular and community service activities
Proficiency in statistical analysis and statistical / visual analysis tools such as Minitab and Tableau preferred
Benefits
Co-Ops/Interns are eligible to participate in Company sponsored employee medical benefits in accordance with the terms of the plan.
Co-Ops and Interns are eligible for the following sick time benefits: up to 40 hours per calendar year; for employees who reside in the State of Washington, up to 56 hours per calendar year.
Co-Ops and Interns are eligible to participate in the Company’s consolidated retirement plan (pension).
Company
Johnson & Johnson MedTech
At Johnson & Johnson MedTech, we are working to solve the world’s most pressing healthcare challenges through innovations at the intersection of biology and technology.