QualityComplianceSpecialist

Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world. A career at Flex offers the opportunity to make a difference and invest in your growth in a respectful, inclusive, and collaborative environment. If you are excited about a role but don't meet every bullet point, we encourage you to apply and join us to create the extraordinary. ## Job Summary **Job summary:** _To support our extraordinary teams who build great products and contribute to our growth, we’re looking to add a** _Quality Compliance Specialist_** located in **_Flex Aguascalientes_**. _ _Reporting to the Quality Manager, the Quality Compliance Specialist is responsible for planning and coordinating the internal validation process to ensure operational optimization and effective alignment with external customer requirements, while supporting the proper establishment, implementation, and maintenance of ISO 13485 requirements and other quality programs._ **What a typical day looks like:** * _Coordinates activities within the organization to hold up process validation requirements._ * _Ensure that validation documentation complies with applicable ISO 13485 / ISO 9001 requirements, internal procedures, and applicable regulatory requirements._ * _Review process validation protocols (IQ, OQ, PQ) to ensure they meet internal requirements, ISO 13485 & ISO 9001, and customer expectations._ * _Provide technical and documentary support to operational areas during the preparation and execution of validations._ * _Coordinate with cross-functional teams (Engineering, Production, Quality) the collection of required evidence._ * _Coordinates activities to drive the resolution of internal and external issues related to process validation._ * _Participate in the proper implementation and effectiveness of the applicable Regulations, Standards, Policies, Directives, and Basic Procedures versus applicable standards in the