Quality Engineering Technician Ii

**"Johnson & Johnson companies are equal opportunity employers"** At Johnson & Johnson, the largest healthcare company in the world, we come together with one purpose: to profoundly change the trajectory of health for humanity. Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years. Regardless of your race, belief, sexual orientation, religion or any other trait, YOU are welcome in all open positions at the largest healthcare company in the world. When You Join Johnson & Johnson, Your Next Move Could Mean Our Next Breakthrough **QUALITY ENGINEERING TECHNICIAN II** **JOB SUMMARY**: - The quality engineering technician provides an active support to BCPs and validations. - The quality engineering technician may supervise FG quality tech and raw material inspection tech. **DUTIES & RESPONSIBILITIES**: Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position: - Generates Non-conformances records in applicable quality information system, as needed - Performs verification of activities already completed under non-conformance reports - Assists or executes failure investigations of non-conformances, audit findings, CAPAs, and other as indicated - Knowledge in Quality Engineering tools such as, measurement system analysis, basic statistics analysis and other as required. - Performs data collection and analysis, creates and distributes reports for quality metrics, initiatives, and/or plant scorecards. - Assist Quality Engineer in line support or per given experience own line support, including the processing of change orders on Documentation control system. - Assist Quality Engineers in driving control plan effectiveness in the mfg lines. - Act as a liaison to manufacturing for quality related issues, as designated. - Maintain control of protocol related materials, ensuring the applicable controls (physical and electronic) are in place and ensuring parties are notified according to Ethicon procedures. - Follows up with the protocol owners for the disposition of protocol materials. - Generates and controls the applicable forms (QA to QA forms) for the transfer of protocol or nonconformance materials between Ethicon sites. - Ensures the environmental / microbiology testing is executed according to the plan; samples are timely collected and submitted for testing according to Ethicon procedures. - Follows J&J and Records Management Policies for Convenience Information, Records Retention Schedules, Training and Education, Document Hold Notices & Records Cleanout. - Maintains, and provides information such as quality records from the company's quality information systems - May act as an administrator of local quality information systems - Responsible in complying with Good Manufacturing Practices (GMPs), Regulations, International Standards, Environmental, and Health Policies - Follows all company safety policies and other safety precautions within the work area - Ensures compliance with safety policies and procedures - Ensures compliance with Environmental Management System (EMS) responsibilities - Ensure compliance with Quality systems policies and procedures - Support protocol and execution of Test Method validation and/or Equipment validation. - Performs Device History Records review and product release (including sterilization information as delegate). These activities require previous training on the applicable procedures. - Verifies that information for rejected material is correctly identified and entered in nonconforming system as material is segregated. - Controls non-conforming components returned from the production floor. - Responsible for tagging material, verify material on hold status in applicable system, logging material in cage, and updating database. - Witness of the appropriate destruction of non-conforming material following the applicable procedures. - Help maintain a document retention system for the Juarez facility. - Coordinates and actively participates on quarterly quality communication meetings - Participates on departmental and company continuous improvement activities on Kaizen blitz, Kaizen or Green belt certification projects. - Provide coaching and support to quality technician on yellow and orange belt projects. - Participate in Test Method and Equipment validations. - Perform change order for document revision as applicable. - Assure that Bioburden, Dose Audit, In Vitro samples are segregate and send to laboratory. - Tracking Laboratory samples and results. - Provide support during External and Internal Audits (e.g.: document retrieval, consultation, etc.) - Responsible for communicating business related issues or opportunities to next management level o For those who supervise or manage a staff, responsi