Quality Assurance Officers

QUALITY SYSTEM SPECIALIST I

The Quality System Specialist I supports the implementation and maintenance of the Quality Management System (QMS). This role is responsible for the coordination and execution of document-centric quality processes, ensuring compliance with applicable regulatory requirements (e.g., The position provides foundational support across QMS elements including document control, change management, and supplier quality activities. Essential Job Functions Coordinate and support quality system activities related to document control, periodic review, and change management processes Maintain high standards for documentation accuracy, completeness, and data integrity within the eQMS Ensure controlled documents and records are maintained in compliance with internal procedures and regulatory requirements Assist in tracking and maintaining supplier quality records and documentation Drive Results Administer document control processes, including routing, revision control, and approval workflows Coordinate periodic document reviews to ensure continued suitability and compliance Work cross-functionally to ensure timely completion of document updates, reviews, and approvals Assist in internal and external audit preparation by providing document and system support Attention to detail with a focus on documentation accuracy, completeness, and data integrity 2+ years in Quality Assurance or a related function within a regulated environment Experience with document control or administrative quality processes, including revision control, record management, or document lifecycle activities Familiarity with quality management system processes (e.g., document control, change control, training, audits) Experience with electronic Quality Management Systems (e.g., ETQ or similar platforms) Experience supporting supplier quality activities or audits preferred Technical writing experience, including development or revision of controlled documents (e.g., Industry Quality Certifications (i.e., Technology/Equipment: Microsoft Office Applications, eQMS software May 2025 Experience Technical writing experience (specifically SOP writing experience) Experience with document control or administrative quality processes, including revision control, record management, or document lifecycle activities Physical Demands Primarily performs work in an office and/or manufacturing environment Prolonged periods of sitting and working at a computer Frequent use of hands and fingers for typing, documentation, and data entry Ability to occasionally stand, walk, and move throughout office and manufacturing areas May be required to review documentation or systems for extended periods to support quality activities Visual acuity sufficient to review detailed documentation, electronic records, and data Working Conditions Primarily office-based with regular interaction within manufacturing and controlled production environments Routine presence on the production floor to support quality activities such as audits, investigations, and process observations Standard Monday-Friday schedule, with flexibility to support production needs, audits, or project timelines Exposure to various manufacturing environments, including controlled or regulated areas, in accordance with site safety and compliance requirements Reporting Structure This position reports to the Director of Engineerin You can read more about us on our website:

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