Quality Systems Specialist — QMS & ISO 9001 Audits

Trystar Inc; Burnsville (MN); On-site; USD 70,000 - 80,000; Full time

Job summary

Trystar Inc. in Burnsville, MN is seeking a Quality Systems Specialist to maintain and improve the QMS, including document control, audits, and CAPA. You will collaborate with Engineering and Operations to ensure procedures reflect practice and drive continuous improvement.

Ideal candidates have 3+ years in quality systems within manufacturing, strong ISO 9001 knowledge, and excellent communication skills. This full‑time role reports to the Quality Leader at our Burnsville location.

Qualifications

• 3+ years of experience in a Quality Systems, Quality Assurance, or Quality Engineering role within a manufacturing environment.
• Hands-on experience supporting or administering a Quality Management System.
• Working knowledge of ISO 9001 requirements.
• Strong attention to detail and ability to manage multiple system-level priorities.
• Strong written and verbal communication skills.
• Internal Auditor certification (ISO 9001).
• Experience with electronic QMS platforms (ETQ preferred).
• Experience supporting audits and corrective action systems.
• Proficiency with Microsoft 365; experience with ERP/MRP systems (Epicor or similar) a plus.

Responsibilities

• Own, maintain, and continuously improve core Quality Management System (QMS) processes including document control, records management, training, internal audits, corrective action (CAPA), nonconformance management, and risk management.
• Administer and govern the document control system within ETQ, ensuring document accuracy, version control, approval discipline, and accessibility across the organization.
• Lead the migration, standardization, and ongoing maintenance of controlled documents and quality records.
• Define, deploy, and track training requirements to ensure employees are properly trained to applicable procedures and quality system requirements.
• Plan, coordinate, and support internal audits and external audits (ISO registrar, customer, and regulatory), including preparation, execution support, and follow up.
• Track audit findings and corrective actions, ensuring timely closure, adequate root cause analysis, and verification of effectiveness.
• Administer the corrective action system, supporting structured problem-solving using methodologies such as 5 Why, Fishbone, and 8D.
• Monitor and report QMS health metrics such as overdue CAPAs, audit findings, document status, and training completion.
• Partners functionally with Engineering, Operations, Supply Chain, and Service to ensure procedures accurately reflect practice and are consistently followed.
• Support management review activities by providing system performance data, trends, and input.
• Coordinate Returned Material Authorization (RMA) activities, including intake, documentation, system tracking, and disposition coordination.
• Perform visual inspection and documentation of returned materials as required to support RMA processing.
• Ensure RMA records, nonconformances, and corrective actions are properly captured within the QMS.
• Identify opportunities to improve QMS effectiveness, usability, and scalability as the organization grows.
• Perform other duties as required.

Job description

Trystar Inc. in Burnsville, MN is seeking a Quality Systems Specialist to maintain and improve the QMS, including document control, audits, and CAPA. You will collaborate with Engineering and Operations to ensure procedures reflect practice and drive continuous improvement.

Ideal candidates have 3+ years in quality systems within manufacturing, strong ISO 9001 knowledge, and excellent communication skills. This full‑time role reports to the Quality Leader at our Burnsville location.