Quality & Regulatory Compliance Manager
- Develop, implement, and maintain the QMS in alignment with industry standards, company objectives and customer expectations.
- Monitor and ensure compliance with local, state, and federal regulations pertinent to logistics and warehousing operations.
- Lead internal and external audit processes, including managing Corrective and Preventive Actions (CAPA).
- Oversee document control practices to ensure accuracy and regulatory compliance.
- Collaborate with cross-functional teams to support quality initiatives and resolve quality-related issues.
- Evaluate and implement changes to QMS policies and procedures in response to regulatory updates or continuous improvement efforts.
- Maintain records of process validations in line with quality and regulatory requirements.
- Conduct training sessions for staff on QMS and regulatory compliance topics.
- Serve as the primary liaison with regulatory bodies and certification agencies.
- High School Diploma or Equivalent Required
- Bachelor Degree in Related Field Preferred
- Minimum 5 Years Experience in Quality or Regulatory Compliance
- Demonstrate Knowledge of QMS Frameworks & Standards (e.g. ISO 9001, ISO 13485 & FDA Regulations
- Demonstrate Proficiency with Microsoft Products (e.g. Excel, Word, Outlook, Teams)
- Minimum 5 Years Experience in Audit Processes, Documentation Control, & Risk Management
- Demonstrate Excellent Organizational & Problem Solving Skills
- Demonstrate Excellent Written and Verbal Communication Skills
- Preferred Experience with Warehouse Management Systems
- Preferred Auditing Certification, as CSCP, CQA, etc.
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