Quality Systems Specialist

MPE-Inc•Milwaukee, WI

8h•$75,000 - $85,000•Hybrid

About The Position

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.

Requirements

Minimum - 2 years of experience in a Quality or Regulatory Affairs role in a GMP related industry
Bachelor’s degree in a scientific, engineering, or business administration discipline or an equivalent combination of education/experience.
Frequent – Seeing, reading, hearing, sitting, listening, decision making, comprehension, computer use, writing, and collaborating
Intermittent – measuring, math, presenting, and lifting up to 40 lbs

Nice To Haves

Working knowledge of quality system standards (QSR/ISO 13485).

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 audit program, checklist preparation, evidence gathering, audit notes, findings, and follow-up actions.
Track audit findings, CAPA actions, complaint actions, and other QMS commitments to closure.
Help prepare for customer audits, ISO audits, and regulatory inspections by organizing objective evidence and records.
Maintain QMS logs, trackers, metrics, and dashboards as assigned.
Support preparation of management review inputs and quality system performance data.
Identify incomplete records, overdue actions, repeat issues, or potential compliance gaps and escalate as needed.
Work cross-functionally with Operations, Engineering, Customer Service, HR, IT, and other departments to support QMS execution.
Assist with other QMS support duties as assigned.