Quality Systems Specialist

About the role

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., FDA, ISO standards) and internal procedures. The position provides foundational support across QMS elements including document control, change management, and supplier quality activities.

Responsibilities

• 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.
• Support accurate, complete, and audit-ready documentation across QMS processes.
• Assist in tracking and maintaining supplier quality records and documentation.
• Administer document control processes, including routing, revision control, and approval workflows.
• Coordinate periodic document reviews to ensure continued suitability and compliance.
• Support execution of change management activities, including tracking and documentation of changes through the Change Control Board.
• Manage and track Supplier-Initiated Change Requests (SICRs), ensuring timely progression and closure.
• Work cross-functionally to ensure timely completion of document updates, reviews, and approvals.
• Support supplier audit activities, including scheduling, documentation, and follow-up actions.
• Assist in internal and external audit preparation by providing document and system support.

Requirements

• 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.
• Experience supporting change management processes, including tracking and coordination of changes.
• 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., SOPs, work instructions) preferred.
• Experience supporting or participating in internal or external audits preferred.
• Technical writing experience (specifically SOP writing experience).

Skills

• Strong organizational and coordination skills across multiple processes.
• Attention to detail with a focus on documentation accuracy, completeness, and data integrity.
• Ability to work effectively across functions and support multiple stakeholders.
• Strong written and verbal communication skills for documentation and reporting.

Qualifications

• A college degree or equivalent experience.
• Industry Quality Certifications (i.e., ASQ) preferred.
• Proficiency in Microsoft Office Applications and eQMS software.

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.
• Ability to occasionally lift and/or move up to 15 pounds.
• 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.
• Frequent interaction with cross-functional teams, including Manufacturing, Engineering, and Supply Chain.
• Exposure to various manufacturing environments, including controlled or regulated areas, in accordance with site safety and compliance requirements.