We are seeking a Quality Systems Coordinator to support controlled documentation activities, change governance processes, and quality system operations for a growing organization operating within a regulated manufacturing environment.
This role will serve as a central resource across quality operations, documentation management, and compliance-related initiatives, helping ensure alignment between internal procedures, product requirements, and regulatory expectations. The position will support change control workflows, document revisions, quality records administration, validation coordination, and cross-functional process improvement efforts while partnering closely with manufacturing, quality, engineering, and operational teams.
Requirements for the Quality Systems Coordinator:
- Bachelor’s degree in life sciences, engineering, quality, operations, or a related technical discipline.
- Several years (3+) of experience supporting quality systems, document control, compliance, or regulated operational functions.
- Working knowledge of regulated quality environments, including cGMP, FDA, and ISO 13485.
- Experience supporting controlled documentation processes, including revisions, approvals, training records, and document lifecycle management.
- Familiarity with change management systems, electronic quality systems, and validation documentation practices.
- Strong organizational and coordination skills with the ability to manage multiple projects, timelines, and quality records simultaneously.
- Ability to communicate effectively across technical and non-technical teams.
- Experience supporting audits, inspections, or compliance readiness activities is preferred.
- Comfortable operating within a fast-paced, cross-functional manufacturing or operational setting.
- Experience with ERP, PLM, LMS, or electronic document management systems is highly preferred.
Responsibilities of the Quality Systems Coordinator:
- Coordinate and maintain controlled documentation activities, including SOP revisions, specification updates, training assignments, and archival support.
- Administer change management workflows including routing, tracking, meeting coordination, follow-up activities, and documentation review.
- Support cross-functional review processes related to product, packaging, labeling, and operational changes.
- Assist with preparation, review, and organization of validation-related documentation including protocols, reports, and execution records.
- Maintain quality system records and ensure documentation accuracy, completeness, and compliance with internal procedures.
- Partner with quality, operations, engineering, procurement, and external partners to support implementation of process or product changes.
- Support audit readiness initiatives by organizing records, compiling documentation, and assisting with inspection preparation activities.
- Track quality system metrics, project milestones, action items, and compliance-related deliverables.
- Contribute to continuous improvement initiatives focused on process consistency, procedural alignment, and documentation efficiency.
- Assist with investigation support activities, data gathering, and follow-up coordination related to quality events or operational deviations.
Occupational Category: 13-1199 Business Operations Specialists, All Other
