Flex
manufacturing
QualityComplianceSpecialist
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Quality Compliance Specialist at Flex. Skills: process validation, ISO 13485, ISO 9001, compliance verification. Coordinate internal validation process. Ensure validation documentation compliance”
What You'll Achieve.
ensure operational optimization; effective alignment with external customer requirements
Industry & Context.
Drive resolution of internal and external issues
What They're Looking For.
Must Have
Advance English, Strong written communication skills, Effective verbal communication skills, Knowledge of process validation principles, Understanding of ISO 13485, Understanding of ISO 9001, Basic awareness of applicable regulatory requirements, Attention to detail, Document review skills, Compliance verification skills, Knowledge of data integrity principles, Knowledge of good documentation practices (GDP), Basic understanding of statistical concepts, Strong time management skills, Prioritization skills
What You'll Do.
Coordinate internal validation process
Ensure validation documentation compliance
Review process validation protocols
Provide technical support during validations
Provide documentary support during validations
Coordinate evidence collection
Drive resolution of validation issues
Participate in implementation of regulations
How You'll Work.
Team & Collaboration
Coordinate with cross-functional teams
Communication Scope
Strong written communication skills; Develop reports; Develop procedural documentation; Effective verbal communication skills; Present information clearly; Respond to questions
Full Job Description
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
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