Quality Systems Associate

Reports to: Quality Control Manager | Non-Exempt | Shift: Monday - Friday, 1st shift

Position Summary

The Quality Systems Associate is responsible for ensuring the accuracy, completeness, and compliance of manufacturing documentation through comprehensive router auditing activities. This role requires a strong understanding of medical device manufacturing processes, quality system requirements, Good Documentation Practices (GDP), and regulatory compliance standards. The position involves reviewing production records, verifying traceability and documentation accuracy, identifying discrepancies, and supporting continuous improvement initiatives within the Quality Management System (QMS). This position plays a critical role in helping EXALTA Group maximize the number of patients served while maintaining the highest standards of product quality, safety, and regulatory compliance.

Responsibilities

• Perform detailed audits of manufacturing routers, travelers, Device History Records (DHRs), and associated production documentation to ensure completeness, accuracy, and compliance.
• Verify that all manufacturing and inspection operations have been completed and documented according to approved procedures and specifications.
• Review production records for proper signatures, dates, revision levels, material traceability, lot control, and compliance with Good Documentation Practices (GDP).
• Identify documentation discrepancies, missing information, and nonconformances, and coordinate timely resolution with Manufacturing, Quality, and Engineering teams.
• Ensure compliance with applicable FDA regulations, ISO 13485 requirements, internal quality procedures, and company policies.
• Support lot release activities through completion of final router audits and production record reviews.
• Participate in investigations related to documentation errors, audit findings, and quality system issues.
• Assist with internal audits and support external regulatory and customer audits as required.
• Maintain accurate records of audit findings and quality metrics.
• Support document control activities, including controlled document reviews and revision verification.
• Monitor trends in documentation errors and provide recommendations for corrective and preventive actions (CAPA).
• Collaborate with cross-functional teams to improve manufacturing documentation processes and enhance quality system effectiveness.
• Provide guidance and training to production personnel regarding documentation requirements and Good Documentation Practices.
• Support quality system initiatives and continuous improvement projects.
• Maintain a clean and safe working environment in accordance with company safety policies and OSHA requirements.

Education/Experience Required and/or Preferred

• High School Diploma or equivalent required.
• Associate Degree in Quality, Engineering Technology, Life Sciences, Manufacturing Technology, or related field preferred.
• Minimum of 2 years of experience in a regulated manufacturing, quality assurance, quality