Quality Compliance Specialist 1

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 dont 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 were 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 organization.

The experience were looking to add to our team:

• Industrial Engineering or similar degree.
• Advance English.
• Strong written communication skills with the ability to develop reports and procedural documentation.
• Effective verbal communication skills including the ability to present information clearly and respond to questions from managers crossfunctional teams and customers.
• Knowledge of process validation principles including IQ OQ PQ revalidation and validation lifecycle concepts.
• Understanding of ISO 13485 ISO 9001 and basic awareness of applicable regulatory requirements (e.g. FDA 21 CFR Part 820).
• Attention to detail and strong document review and compliance verification skills.
• Knowledge of data integrity principles and good documentation practices (GDP).
• Basic understanding of statistical concepts commonly used in process validation (e.g. sampling rationale capability awareness).
• Strong time management and prioritization skills to meet validation and audit deadlines.

What youll receive for the great work you provide:

• Competitive Salary.
• Life & Medical insurance.
• Christmas Bonus.
• Food Coupons.
• Saving Fund.

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Flex is an Equal Opportunity Employer and employment selection decisions are based on merit qualifications and abilities. We do not discriminate based on: age race religion color sex national origin marital status sexual orientation gender identity veteran status disability pregnancy status or any other status protected by law. Were happy to provide reasonable accommodations to those with a disability for assistance in the application process. Please email and well discuss your specific situation and next steps (NOTE: this email does not accept or consider resumes or applications. This is only for disability assistance. To be considered for a position at Flex you must complete the application process first).