Quality Systems Specialist
About The Position
The Quality Systems Specialist is responsible for supporting, maintaining, and continually improving the company’s Quality Management System (QMS) and its associated subsystems. This role focuses on the development, control, and maintenance of Objective Quality Evidence (OQE) to demonstrate compliance with applicable standards, customer requirements, and regulatory obligations. The position plays a key role in internal and external audits, corrective action activities, and integration of quality system requirements into operational and safety-related processes. Success in this role requires strong organizational skills, technical aptitude, persistence, and the ability to see tasks through to completion. This role is granted organizational independence to report quality system performance, audit results, and compliance concerns without undue influence, and to elevate issues impacting product quality, system effectiveness, or safety.
Requirements
- Associate’s degree, technical training, or equivalent experience in quality, manufacturing, or a related field
- 3–6 years of experience in quality assurance, quality systems, or a regulated manufacturing environment
- Working knowledge of Quality Management Systems (ISO 9001, AS9100, or equivalent)
- Demonstrated experience developing and maintaining Objective Quality Evidence (OQE)
- Ability to read and interpret engineering drawings, specifications, procedures, and controlled documents
- Strong organizational skills with the ability to manage multiple tasks from assignment through completion
- Proven persistence and follow-through in resolving incomplete or missing documentation
- Ability to work independently with minimal supervision
Responsibilities
- Support the maintenance and improvement of the Quality Management System in accordance with ISO 9001 / AS9100 and applicable customer and regulatory requirements
- Administer and support QMS subsystems, including but not limited to: Document and record control Corrective and preventive action (CAPA) Risk management activities Training and competency records Supplier quality system interfaces
- Ensure quality procedures, work instructions, and records are current, controlled, and properly implemented
- Develop, assemble, review, and maintain Objective Quality Evidence (OQE) packets to demonstrate process and product compliance
- Read and interpret engineering drawings, specifications, procedures, and customer requirements to determine required evidence
- Proactively chase down missing or incomplete documentation across departments to ensure OQE packages are complete, accurate, and audit-ready
- Ensure quality evidence is objective, traceable, and generated at the point of work
- Plan, conduct, and document internal quality audits in accordance with the established audit program
- Support external audits, including certification audits, customer audits, and regulatory audits
- Track audit findings, corrective actions, and verification of effectiveness
- Identify systemic issues and opportunities for improvement based on audit results and trend analysis
- Support the corrective action process, including: Development of clear problem statements Evidence-based root cause analysis Verification of corrective action effectiveness
- Monitor and report on quality system performance metrics
- Support continual improvement initiatives aligned with company quality objectives
- Support integration of quality system requirements into the company safety program
- Assist with documentation control, corrective action tracking, and audit activities related to safety
- Support investigations and follow-up activities related to safety incidents as required
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Associate degree
