Flex
QualityComplianceManager
Neural analysis suggests this role is
optimal for Manager candidates.
“Quality Compliance Manager at Flex. Skills: Quality Compliance, Regulatory Audits, Quality Systems. Supervise the site's Quality Compliance team. Assure conformance of regulatory and quality systems requirements”
What You'll Achieve.
Achieve quality goals; Exceed quality goals
Industry & Context.
Strong problem-solving skills
What They're Looking For.
Must Have
Bachelor's degree in Engineering or related, Senior experience developing, implementing and maintaining quality systems or related area, Advanced/thorough knowledge of relevant regulatory standards and applicable regulations, Knowledge of Regulatory And Quality Audits Process, Knowledge of Regulations and Quality Standards, Knowledge of ISO9001, Knowledge of ISO13485, Knowledge of FDA 21 CFR Part 820, Knowledge of Internal Quality Systems Manuals, Knowledge of Level 1 procedures, Knowledge of Manufacturing Processes, Knowledge of Regulatory Agencies, Good relational skills, Good negotiation skills, Demonstrates detailed expertise in very complex functional/technical area or broad breadth of knowledge in multiple, Strong problem-solving skills
What You'll Do.
Supervise the site's Quality Compliance team
Assure conformance of regulatory and quality systems requirements
Perform internal audits
Review results from Quality Compliance team
Identify trends and opportunities for improvement
Verify compliance and conformance to regulatory and quality
Engage in External Audit Processes
Verify implementation and effectiveness of Regulations
Help areas implement regulatory and quality requirements
Develop training programs for internal users
Execute formation of Regulatory and Quality Systems skilled
Develop Internal / External Audits Programs
Prepare the Audit Plan
Prepare Audit Checklists
Execute Audits according to the plan
Prepare audit reports
Maintain all audit related records
Plan Area/Process Audit
Execute Area/Process Audit
Follow up Area/Process Audit
Identify Non-Conformance
Identify Opportunities for Improvement
Document all audit findings
Request corrective actions
Request preventive actions
Participate as a key member for all external
Maintain records as required
Follow up on internal corrective actions
Follow up on external corrective actions
Ensure timely implementation of corrective actions
Validate effectiveness of corrective actions
How You'll Work.
Team & Collaboration
Quality Compliance team; Site organization
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 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 Syste
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