Quality Assurance Operations Engineering Technician

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 Med Tech, 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

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Learn more at

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 Med Tech, 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

Quality

Quality Control

Business Enablement/Support

Irving, Texas, United States of America

Responsible for conducting technical quality assurance inspections, quality issue resolution, product containment, and supporting quality improvements for production processes.

• Supports Quality Operation functions including: CAPA/NC initiatives, Quality “presence” on the manufacturing floors, and proactive GDP and Data Integrity.
• Assist with data collection for quality metrics, quality improvement initiatives, CAPAs, NCs, or Quality Systems.
• Perform data searches and transactions within MES, JDE, and EtQ.
• Partner with QEs and business partners (and other NC “owners”) providing support with NC process, investigations, and/or corrective actions.
• Primary coordinator for APMER related items such as request, documentation, closure, and transactions.
• Support periodic review activities related to Quality Operations.
• Perform Cycle Review activities.
• Perform Operator certification for defect inspections.
• Conduct failure investigations, root cause analysis, and product complaint investigations.
• Provide BOP, Internal audit, and external audit support.
• Read and interpret drawings, QCIC's and test methods.
• Develop, prepare, and report technical information to management to identify, segregate and disposition product through the nonconforming system.
• Support handling and disposal activities for scrap, obsolete, or unusable materials

• 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.

• High School Education or GED is required, bachelor’s degree preferred.
• Minimum of two (2) years of experience in a manufacturing environment is required.
• Ability to perform duties in accordance with policies and procedures.
• Experience in the Medical Device industry or medical field preferred.

• Previous experience in non-conformance investigations and root cause analysis desired.
• Attention to detail and robust documentation practices are required.
• Must be able to communicate specifications and procedures.
• Must be able to work both independently and within cross-functional groups.
• Proficiency in ETQ, JDE, MES, MS…