Quality Compliance Specialist

Job Posting Start Date 01-08-2025 Job Posting End Date 03-24-2025

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

The Quality Compliance Specialist will be based in Buffalo Grove, IL, reporting to Director of Quality. The Quality Compliance Specialist 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 a 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 Flext 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're looking to add to our team:

• Typically requires a bachelor's degree in related field or equivalent experience.
• 2 years of CAPA, nonconformance experience
• 2 years of technical writing experience
• 2+ years of medical devices/ pharma or biotech industry experience
• QMS experience.

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

• Full range of medical, dental, and vision plans
• Life Insurance
• Short-term and Long-term Disability
• Matching 401(k) Contributions
• Vacation and Paid Sick Time
• Tuition Reimbursement

Pay Range (Applicable to Illinois)

$59,100.00 USD - $81,300.00 USD Annual

Job Category
Quality

Is Sponsorship Available?
No

Flex is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. We celebrate diversity and 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).