Quality Compliance Specialist

• Ensure compliance with all applicable regulatory, customer, and Quality Management System (QMS) requirements.
• Conduct internal audits to assess compliance with regulatory, customer, and organizational quality system requirements.
• Support and participate in external audits conducted by customers, certification bodies, regulatory authorities, and government agencies.
• Evaluate the implementation and effectiveness of applicable regulations, standards, policies, and procedures across the organization.
• Provide guidance and support to functional teams in implementing regulatory and quality system requirements.
• Develop and deliver training programs related to quality systems, regulatory compliance, and audit requirements.
• Promote quality and compliance awareness throughout the organization.
• Develop and maintain the Internal Audit Program in accordance with applicable standards and business requirements.
• Coordinate and manage external audit schedules and activities.
• Prepare audit plans, audit schedules, and audit checklists.
• Execute audits according to the approved audit plan, prepare audit reports, and maintain audit records.
• Conduct process, system, and area audits as required by the organization.
• Document audit findings, including nonconformities, observations, and opportunities for improvement.
• Initiate and track corrective and preventive actions (CAPA) resulting from audit findings.
• Maintain audit documentation and records in compliance with quality system requirements.
• Follow up on corrective actions to ensure timely closure and verify their effectiveness.
• Monitor and communicate updates to applicable regulations, industry standards, and quality system requirements.

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

• Typically requires a Bachelor’s degree in related field or equivalent experience and training.
• Typically requires minimum 4 years of relevant experience.

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

• Full range of medical benefits, dental, vision
• Life Insurance
• Paid Time Off
• Allowances & Bonuses

HH39

AA98

Job Category

Quality

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).