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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 Manager located in Aguascalientes.
Reporting to the Quality Manager, Quality Compliance Manager will be in charge of Regulatory and Quality Systems Internal Audits. Help the Quality Compliance team and site organization to conform and comply with regulations, internal policies, directives, and procedures in order to achieve and exceed the quality goals expected by the customer and the organization
What a typical day looks like:
- Hold up and may supervise the site's Quality Compliance team to assure the conformance of all organization's regulatory and quality systems requirements.
- Perform internal audits and/or review results from Quality Compliance team to identify trends and opportunities for improvement. Verify compliance and conformance to all regulatory and quality systems requirements, including both Customer and Flex mandated.
- Engage in External Audit Processes (Customers', Regulatory, Government Agencies, etc.).
- Verify the proper implementation and effectiveness of the applicable Regulations, Standards, Policies, Directives and Level 1 Procedures in the organization.
- Help 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.
- Execute the formation of Regulatory and Quality Systems skilled employees that help the organization.
- Develop Internal / External Audits Programs.
- Prepare the Audit Plan and related Audit Checklists.
- Execute Audits according to the plan, prepare the audit reports and maintain all audit related records.
- Plan, execute and follow up any Area/Process Audit when required by the organization.
- Create audit reports that identify any Non-Conformance or Opportunities for Improvement found during the audit process.
- Document all audit findings and request the corrective / preventive actions needed.
- 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 Engineering or related.
- Senior experience developing, implementing and maintaining quality systems or related area
- Must have advanced/thorough 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 Level 1 procedures Manufacturing Processes, Regulatory Agencies. Has awareness of the functional impact upon work processes and other functions. Must have good relational and negotiation skills. Must have knowledge of relevant regulatory standards and applicable regulations.
- Demonstrates detailed expertise in very complex functional/technical area or broad breadth of knowledge in multiple areas; recognize the strategic impact of the function across sites.
- 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
Job CategoryQuality
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 accessibility@flex.com 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).
