at Flextronics International USA Inc. in Buffalo Grove, Illinois, United States
Job Description
Job Posting Start Date 07-30-2024 Job Posting End Date 09-09-2024
Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world.
We believe in the power of diversity and inclusion and cultivate a workplace culture of belonging that views uniqueness as a competitive edge and builds a community that enables our people to push the limits of innovation to make great products that create value and improve people's lives.
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
We are seeking a Quality Compliance Specialist at our Buffalo Grove IL Facility. In this role, you will be in charge of the Regulatory and Quality Systems Internal Audits. Holds up the 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 at typical day looks like:
- Assuring the conformance of all organization's regulatory and quality systems requirements.
- Performing internal audits to 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 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.
- Execute the formation of Regulatory and Quality Systems skilled employees that help holds up the organization.
- Develop Internal Audits Programs.
- Management of external Audits Programs.
- Prepare the Audit Plan and related Audit Checklists.
- Execute / Manage 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 effectives.
- Stay up to date on New/Revised Regulations, Standards, Policies, Directives and Level 1 Procedures.
The experience we are looking to add to our team:
- Typically requires a Bachelors degree in related field or equivalent experience.
- Typically requires 2 years of experience within Quality compliance
- Understanding of audits, audit plans, FDA regulations.
- Experience working within Healthcare/ Medical Manufacturing preferred.
Here...
Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity
