Quality Systems Specialist

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Full Time Quality Milwaukee, WI, US

4 days ago Requisition

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 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 elevate 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.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position

The above list reflects the general details necessary to describe the principle and essential functions of the position and shall not be construed as the only duties that may be assigned for the position.

Education

• Bachelor’s degree in a scientific, engineering, or business administration discipline or an equivalent combination of education/experience.

Experience and/or Training

• Minimum - 2 years of experience in a Quality or Regulatory Affairs role in a GMP related industry
• Preferred - Working knowledge of quality system standards (QSR/ISO 13485).

Physical and mental demands

• Frequent – Seeing, reading, hearing, sitting, listening, decision making, comprehension, computer use, writing, and collaborating
• Intermittent – measuring, math, presenting, and lifting up to 40 lbs

The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Standard office environment. Will require going into production areas which may be hot, cool, dusty, and have a moderate noise level.

The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position