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Ingeniero de sistemas de calidad NC EMI

Onsite, Tijuana, Baja California

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ID de la oferta
R-544017
Category
Quality
Location
Tijuana, México
Region
LATAM

We are the people who give possibilities purpose

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

Job Description

·Familiarity with FDA, ISO, and ANSI regulations and standards (For Ex: ISO 9001, ISO 13485, ISO 14971, 21 CFR Part 820, QMSR).

·Creates necessary procedures and forms to support the Quality Management system.

·Participates in internal, external, and 3rd party quality audits.

·Act as the primary point of contact for Global Hold activities across multiple functions, including Design, Labeling, Operations, and Quality.

·Coordinate the opening of Global Hold records, ensuring accurate and complete documentation.

·Clearly define the scope of the issue in collaboration with Subject Matter Experts (SMEs) from impacted processes.

·Track and follow up on open Global Holds to ensure timely progress, resolution, and closure.

·Identify and proactively escalate risks, delays, or roadblocks to upper management when resolution timelines are at risk.

·Ensure Global Hold activities are executed in accordance with quality system procedures, regulatory requirements, and internal timelines.

·Maintain clear communication with stakeholders by providing status updates, action items, and escalation summaries as needed.

·Provide guidance and training on proper GH initiation, documentation, and closure.

·Collaborates on Corrective and Preventive Actions and process improvement projects.

·Lead continuous improvement activities related across the EMI hub and serve as an EMI SME for elements of the QMS in scope of the role.

·Independently handles routine tasks with meticulous attention to detail.

·Ensure data accuracy, completeness, and consistency across systems and reports.

·Performs any other assigned duties and responsibilities.

·Prepare executivelevel presentations and detailed meeting minutes that summarize key metrics, trends, and status of Global Holds and Nonconformance (NC) records.

Why Join Us?

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

To learn more about BD visithttps://bd.com/careers.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.

Required Skills

Optional Skills

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Primary Work Location

MEX Tijuana - Parque Sur

Additional Locations

Work Shift

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