Digitalization Quality Manager
J&J Family of Companies
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 MedTech, 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 https://www.jnj.com
**Job Function:**
Quality
**Job Sub** **Function:**
Digital Quality
**Job Category:**
People Leader
**All Job Posting Locations:**
Ciudad Juarez, Chihuahua, Mexico
**Job Description:**
**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.
Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech
**About Cardiovascular**
Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.
Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.
Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech
**We are searching for the best talent for Digitalization Quality Manager for Plant Salvarcar, Ciudad Juarez, Chihahua.**
**Purpose:**
An experienced and innovative Manager of Digitalization – Quality Systems that leads our digital transformation within the Quality organization. This role is critical in shaping the future of quality operations by planning, coordinating, and directing quality assurance digitization programs consistent with established standards. Successful implementation of a scalable digital solutions, integration of AI-driven technologies, and enabling real-time visibility of key quality metrics. A visionary and a hands-on role in which the intersection of technology, data, and quality excellence, possessing the ability to inspire teams and drive impactful change in quality processes.
**You will be responsible for** **:**
In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
+ Implement and scale AI-based Quality Assurance tools: Support the use of tools like GenAI for quick decisions and automated analysis. Promote and lead quality improvement initiatives and projects that generate cost savings and enhancements in processes and products.
+ Review and analyze the effectiveness of improvement methodologies: Evaluate techniques such as PDCA, Six Sigma, Kaizen, and Lean; conduct benchmarking for the development of effective improvement methods; and establish quality metrics aligned with the plant's objectives.
+ Develop documentation and quality systems: Maintain quality assurance documentation, ensure compliance with standards (QSRs, ISO 13485), and conduct periodic audits to assess GMPs and quality controls that enable corrective actions.
+ Cost and budget management: Monitor the Cost of Poor Quality (COPQ) and manage the central department budget, ensuring profitability and adequate funding for quality activities.
+ Collaboration in product validation: Work with operations and engineering departments on validation strategies and new product introductions, supporting digital developments for monitoring and controlling processes.
+ Lead and deploy data management tools: Implement Power BI dashboards that provide real-time information to quality leaders, as well as ensure data consistency across operational levels.
+ Management of non-conformities and problem resolution: Collaborate on the review and documentation of non-conformities, corrective actions, and customer complaints; provide guidance for solving technical problems in manufacturing.
+ Maintenance of CTQs and customer satisfaction: Support the periodic review of CTQs in manufacturing to ensure ongoing customer satisfaction and use innovative tools for risk detection.
+ Strategic planning and team development: Work on strategic planning in collaboration with site and operations leaders. Provide supervision and mentoring for personnel development and ensure adherence to health, safety, and environmental guidelines.
+ Ensure data is created for analysis purposes, decision making process and is communicated to drive improvement actions
+ Strategize data analytics is shared through the organization at the different levels and cross functional departments.
+ Communication and regulatory compliance: Communicate business issues or opportunities, ensure compliance with local and federal regulations and policies, and ensure that subordinates follow the company's health and safety guidelines.
+ Performs other duties assigned as needed
**Qualifications / Requirements:**
+ Bachelor’s degree in a technical or analytical field (Engineering, Life Sciences, Data Analytics, etc.), with a Master’s or Ph.D preferred
+ 8-10+ years of experience in manufacturing, quality systems, or business intelligence, focusing on digital transformation and operational excellence.
+ Advanced proficiency in PowerBI, including data modeling, DAX, and interactive dashboard development.
+ Strong experience with ETL processes and integrating data from various systems (ERP, MES, SharePoint, Excel) into centralized reporting solutions.
+ Proven ability to lead cross-functional initiatives across operations, quality, and IT, implementing KPI dashboards and automated reporting frameworks.
+ Deep understanding of continuous improvement principles, with practical experience in Lean Six Sigma methodologies.
+ Comfortable in regulated environments, familiar with digital quality system requirements (audit trails, electronic records).
+ Excellent communication skills and stakeholder management, capable of translating business needs into digital solutions and influencing decision-making.
+ Proficiency in computer software packages. (PowerBI, AI, Digital Tools)
+ Ability to effectively engage and negotiate with representatives from various internal and external departments.
+ Excellent communication skills in English, both written and oral.
+ Ability to perform “active involvement” in problem-solving and resolution is preferred.
+ Capacity to solve problems and provide good judgment is highly desired.
+ Ability to present strategies and strategy implementation updates including improvement actions driven from data analysis, at a higher organizational level.
+ Certification as CQA, CQE, CQM (preferred), CBA, GB, BB, or MBB is a plus.
+ Medical Device Industry experience is preferred.
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