Quality Compliance Specialist

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:

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 Aguascalientes.

Reporting to the Quality Manager, Quality Compliance Specialist will be in charge of the Regulatory and Quality Systems Internal & External Audits. Holds up the organization to conform and comply with regulations, internal policies, directives, and procedures to achieve and exceed the quality goals expected by the customer and the organization.

What a typical day looks like:

• Establishes regulatory compliance programs and procedures such as ISO documentation to ensure ongoing compliance with agency, and/or government regulations. Use internal/external experts where appropriate.
• Coordinates corrective actions
• Identifies needs for evaluation/assessment with regards to regulatory issues and conducts or enlists internal/external experts to investigate, test and/or audit. Recommends corrective action to management and implements approved solutions. Follows up to ensure compliance.
• Develops and communicates site procedures to facilitate employee and process compliance. Assists in policy development. Develops and maintains documentation.
• Develops and coordinates audit and training programs. May conduct training and advise management of employees training compliance status
• Performs internal audits to verify compliance and conformance to all regulatory and quality systems requirements.
• Engage in External Audit Processes (Customers', Regulatory, Government Agencies, etc.)
• Verify the proper implementation and effectiveness of the applicable Regulations, Standards, Policies, Directives and Basic Procedures versus applicable standards in the organization.
• Provide holds up to any area that requires help to implement regulatory and quality requirements into their processes.
• Develop training programs for internal users in subjects related to Regulations or Quality Systems
• Participate as a key member for all external audits activities and maintain records as required.
• Follow up on internal and external corrective actions to ensure timely implementation and validate their effectiveness.

The experience we’re looking to add to our team:

• Bachelor’s degree in related field.
• Experience in engineering in the high technology electronics industry or related field
• Must have knowledge of relevant regulatory standards and applicable regulations.
• Regulatory And Quality Audits Process Regulations and Quality Standards (Must: ISO9001, ISO13485, FDA 21 CFR Part 820).
• Internal Quality Systems Manuals and Basic Procedures versus applicable standards in the organization. Manufacturing Processes.
• Strong problem-solving skills.

What you’ll receive for the great work you provide:

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

XS65

Required Skills:

Optional Skills:

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. We're happy to provide reasonable accommodations to those with a disability for assistance in the application process. Please email [email protected] and we'll 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).