Responsibilitiesfamiliarity with fda, iso, and ansi regulations and standards (e.g., iso *, iso *, iso *, 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.maintain data integrity and audit readiness of all nc records.coordinate with quality engineering, manufacturing, supply chain, and supplier quality to ensure effective investigation and disposition of non-conforming product/material.provide guidance and training on proper nc initiation, documentation, and closure.ensure timely progression of ncs through the workflow and escape overdue or stalled records.verify electronic disposition in erp systems aligns with physical inventory status.generate and maintain metrics, including aging, cycle time, disposition trends, and recurrence.identify patterns or systemic issues and recommend improvements.contribute to updates of nc procedures, forms, and work instructions.support coordination of documentation and execution of global holds.collaborates on corrective and preventive actions and process improvement projects.lead continuous improvement activities 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.prepare executive‐level presentations and detailed meeting minutes that summarize key metrics, trends, and status of global holds and nonconformance (nc) records.performs any other assigned duties and responsibilities.locationprimary work location: mex, tijuana - parque suradditional locations: tbdwork shift: tbdequal opportunity employerbecton, 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.
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