Quality Engineering Co Op
: Job Details :

SECTION 1: JOB SUMMARYThe Quality Engineer Co-Op shares a passion for ensuring the highest quality experiences for our patients and customers. This position will be responsible for the support of Quality Engineering activities pertaining to Design Controls, Product & Process Validation, Risk Management, and Lifecycle Management for the Wound Closure and Healing (WCH) or the Biosurgery Platforms. WCH is a market leader in surgical tissue healing with a broad portfolio including Antibacterial sutures, Knotless Tissue Control Devices, Topical Skin Adhesives, Skin Closure Systems, and traditional absorbable and non-absorbable surgical sutures with innovative needle technologies. The Biosurgery Platform consists of a comprehensive portfolio of adjunctive hemostats and sealants.SECTION 2: DUTIES& RESPONSIBILITIESIn accordance with all applicable federal, state and local laws/regulations and Corporate Johnson& Johnson, procedures and guidelines, this position:* 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.