Head Of Business Quality - Americas

What you will doThe Regional Head of Business Quality is a leadership role responsible to manage all aspects of quality assurance and providing close support/service to assigned Region.
Manage quality related processes and topics for all sites within the region including: QMS, QA Ops, QA CS, RA.
Manages all aspects of daily execution of strategy, procedures and processes on regional and local level related to quality assurance in manufacturing, sales and distribution operationsWhat you bringBusiness QualityManage daily execution of strategy, procedures and processes on regional and local level.Create region-specific quality plans and action steps to achieve operational and regulatory compliance.Ensure implementation and maintenance of local QMS and all associated processes and procedures.Ensure implementation processes supporting local manufacturing/sales/distribution operations, supplier quality management, regulatory compliance and overall quality management system to ensure compliance to regulatory requirements e.g.
ISO 13485 certification and CFR 21 QSR FDA part 820.To ensure support and guidance on key OPS topics like local complaint investigation, Change control, NPI/Design Transfer, Process Control & Validation, Incoming Inspection and Supplier Management.