**Job Function**:Quality**Job Sub Function**:Quality Systems**Job Category**:Professional**All Job Posting Locations**:Ciudad Juarez, Chihuahua, Mexico, São José dos Campos, São Paulo, Brazil**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.United States and Puerto Rico- Requisition Number: R-********We are searching for the best talent for a Staff Quality Engineer - Escalations role.**The Staff Quality Engineer is responsible for the end-to-end process related to product quality issue escalations through the decision-making framework of risk management and quality review boards to inform and support decisions to initiate field actions when appropriate.**Key Responsibilities**:- Execute and lead all associated activities related to the product risk escalation/assessment process to ensure compliance with internal and external requirements.- Execute the overall escalation process from issue identification to presentation at the Risk Management Board (RMB) as well as the Quality Review Board (QRB), when required.- Collect, create and review escalation documentation to ensure robustness and compliance.- Prepare meeting content to the Risk Management Board and/or Quality Review Board to help facilitate the determinations of field actions and run the escalation meetings at the Risk Management Boards.- Appropriately utilize risk management within the escalation process.- Partner with Quality Operations, Compliance, Regulatory, R&D;, Medical Safety, as well as other organizations who may own portions of a given product issue escalation.- Provide periodic reports, presentations,



and metrics related to product risk escalations to upper management as needed.- Aspire to and effectively call peers to action and higher levels of accountability.- Partner with and influence internal and external stakeholders to drive needed change and the execution of compliance related matters.- Support data requests for audits, post market surveillance, regulatory registrations, etc, as well as provide data for periodic reports, presentations, and metrics related to product risk escalations.- Implement/modify quality systems to address changing regulations or industry standard, providing regulatory interpretation and guidance where required.- Support the growth of other team members, so the pipeline of J&J; talent remains strong well into the future.- Other responsibilities include but are not limited to: coordinate and participate in special projects as assigned; act as backup support for product escalation Quality Engineers or other product Field Action teams.- Participate in various projects in the spirit of continuous improvement.- Actively participate in audit and compliance review processes.- Demonstrate customer support and maintaining knowledge of Ethicon products and services.- Plan, coordinate and execute the onboarding training of new associates and/or existing associates.- Identify, lead and/or support appropriate projects towards desired business outcomes.- Promote a work environment that challenges the status quo, leads and adapts to change,



as well as creates significant positive changes in the workplace.- Create a trusting, collaborative, and ethical work environment that positively contributes to employee engagement and retention.- Support all needed Quality System and business related requests for data analysis, QSMR, BPDR, QRB, DRB, CAPA, NC, etc.**Qualifications****Education**:- A minimum of a Bachelor's degree or equivalent in scientific and/or engineering discipline is required.**Experience and Skills**- Minimum of 6 years of related work experience is required.- Experience in the medical device, pharmaceutical or other highly regulated industry preferred.- Knowledge of ISO and/or cGMP regulations is preferred.- Experience in an FDA regulated environment is an asset.- An ASQ certification (CQE, CQM, CRE or CQA) is an asset.- Six Sigma (Green Belt, Black Belt, etc.) or Process Excellence certification is an asset.- Basic knowledge in Statistics, Sampling Planning, Risk Assessment and Process Validation is preferred.- Able to communicate effectively at all levels within Quality as well as cross functionally with departments such as R&D;, Regulatory, Operations, Medical Affairs, Medical Safety, Compliance, Manufacturing, etc.- Experience with internal/external audits, Risk Management, and recruiting/onboarding of prospective team members is preferred.- Experience leading collaborative efforts within teams and implementing continuous improvement activities is preferred.- Proven ability to successfully execute increased business responsibilities while maintaining high levels of productivity and quality of work.- Excellent interpersonal relations, influencing and communication skills are required.- Strong oral and written communications

📌 Job Posting Title Staff Quality Engineer - Escalations (Ciudad Juárez)
🏢 Johnson & Johnson
📍 Ciudad Juárez