Quality Compliance Specialist (Aguascalientes)

Quality Compliance Specialist (Aguascalientes)

05 ago
|
Flex
|
Aguascalientes

05 ago

Flex

Aguascalientes

Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world.
**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_**_.
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- 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 ***** 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 ***** / ISO **** requirements, internal procedures, and applicable regulatory requirements._
- _ Review process validation protocols (IQ, OQ, PQ) to ensure they meet internal requirements, ISO ***** & ISO ****, 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 organization._
**The experience we're looking to add to our team**:
- _ Industrial Engineering, or similar degree.
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- _Advance English._
- _ Strong written communication skills, with the ability to develop reports and procedural documentation.
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- _Effective verbal communication skills, including the ability to present information clearly and respond to questions from managers, cross‐functional teams, and customers.
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- _Knowledge of process validation principles, including IQ, OQ, PQ, revalidation, and validation lifecycle concepts.
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- _Understanding of ISO *****, ISO ****, and basic awareness of applicable regulatory requirements (e.g., FDA 21 CFR Part 820).
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- _Attention to detail and strong document review and compliance verification skills.
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- _Knowledge of data integrity principles and good documentation practices (GDP).
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- _Basic understanding of statistical concepts commonly used in process validation (e.g., sampling rationale, capability awareness).
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- _Strong time management and prioritization skills to meet validation and audit deadlines.
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**What you'll receive for the great work you provide**:
- _ Competitive Salary._
- _ Life & Medical insurance._
- _ Christmas Bonus._
- _ Food Coupons._
- _ Saving Fund._
XS65
**Job Category**: Quality
**Required Skills**:
Optional Skills:

📌 Quality Compliance Specialist (Aguascalientes)
🏢 Flex
📍 Aguascalientes

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