04 feb
Abbott Laboratories
Xico
.Quality Systems Engineer - Queretaro SiteQuality Systems Engineer - Queretaro SiteApply locations Mexico - QueretaroTime type: Full timePosted on: Posted 2 Days AgoTime left to apply: End Date: February 15, 2025 (12 days left to apply)Job requisition id: 31109193JOB DESCRIPTION:MAIN PURPOSE OF ROLETo integrate and maintain quality systems in Querétaro in accordance with all applicable regulations, standards and Abbott/AQ policies/Mexican regulations.
This includes but is not limited to proactive implementation and maintenance of compliance of the divisional quality system and site-specific procedures and practices, search and application of integration initiatives and improvements.
This role is intended to work independently on the leadership within Querétaro for all-across application of the system and may have supervision responsibilities of direct reports within quality systems organization.MAIN RESPONSIBILITIESProvides Quality System Body of Knowledge support to the organization.Lead cross functional teams to execute Quality System initiatives.As appropriate, participate in or lead teams in supporting quality disciplines, decisions, and practices (e.G., represent the Quality System function as a Team Member).Draft, review, and update Quality Systems support documentation to proactively comply with applicable internal, domestic, and international standards or regulations.Support and execute internal/external Quality System audits.Ensures compliance to all Quality System Regulations and policies applicable to business units in Querétaro by providing support for interpretation of regulations,
performing gap analysis and leading activities to implement improvements.Identify opportunities for improvement regarding compliance to all Quality System Regulations and policies applicable to business units in Querétaro.Supports, executes, and resolves investigations related either to non-conformances or improvement opportunities.Works with the organization during new product introductions to ensure quality deliverables, write Quality Plans and ensure Risk Management are in place for the products being transferred.Evaluates regulations to translate requirements into user friendly Standard Operating Procedures and Work Instructions.Supports the CAPA System elements for the site.Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.Might be responsible for specific areas within the quality systems organization, driving for excellent operative execution and personnel management (facilitation,
training and development).Performs other duties and responsibilities as assigned.Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
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