Full Time
Quality
Milwaukee, WI, US

Salary Range: $75,000.00 To $85,000.00 Annually


Job Summary:

The Quality Systems Specialist reports to the Quality Director and supports the maintenance and execution of the company’s Quality Management System. This role assists with document control, training, internal audits, CAPA tracking, complaint/RMA quality records, QMS metrics, and audit readiness. This position works with Quality leadership and process owners to help ensure QMS records are complete, controlled, and inspection ready.

Essential duties and responsibilities:


+ Support administration of QMS processes in accordance with ISO 13485 and quality system requirements.

+ Assist with document change requests, document routing, approvals, revision control, release, and archival.

+ Support training assignments related to new or revised documents and follow up on overdue training.

+ Lead the internal ...