Quality Systems Lead - ISO 9001 & CAPA Expert

Trystar; Burnsville (MN); On-site; USD 65,000 - 90,000; Full time

Job summary

Trystar, based in Minnesota, is seeking a Quality Systems Specialist to maintain and improve our QMS across document control, training, records, and audits. You will partner with Engineering, Operations, and Supply Chain to ensure compliant, efficient processes and drive continuous improvement.

The role reports to the Quality Leader and emphasizes problem solving using methods like 5 Why, Fishbone, and 8D, with a focus on CAPA closure, audit readiness, and metrics tracking.

Qualifications

• 3+ years 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.

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.

Skills

Quality Management

Auditing

Document Control

CAPA

Process Improvement

Tools

ETQ

Epicor ERP

Microsoft 365

Job description

Trystar, based in Minnesota, is seeking a Quality Systems Specialist to maintain and improve our QMS across document control, training, records, and audits. You will partner with Engineering, Operations, and Supply Chain to ensure compliant, efficient processes and drive continuous improvement.

The role reports to the Quality Leader and emphasizes problem solving using methods like 5 Why, Fishbone, and 8D, with a focus on CAPA closure, audit readiness, and metrics tracking.