Full-Time
Quality System Specialist
at
VitalPath
Available Openings: 1
Posted Date: September 30, 2026
Industry: Manufacturing
Pay Type: Salary
Compensation: $70,000 - $82,000
Education Level: Bachelor's Degree
Description
The Quality Systems Specialist supports the execution and maintenance of a harmonized quality Management System (QMS) across multiple manufacturing sites within a regulated medical device environment. This role supports core quality systems process including document control, training compliance, CAPA coordination, change control administration and audit readiness activities. In partnership with cross-functional teams to ensure the quality system activities are executed consistently and in compliance with FDA, ISO 13485, customer and internal quality requirements.
Responsibilities
- Support the administration and maintenance of a harmonized Quality Management System (QMS) across multiple manufacturing sites.
- Coordinate quality system processes including document control, training management, change control, deviations, and CAPA activities.
- Maintain quality records to ensure completeness, accuracy, and compliance with applicable regulatory requirements and internal procedures.
- Support administration of the QCBD training management system, including training assignments, training record maintenance, and compliance monitoring.
- Assist departments in resolving routine quality system and training compliance issues.
- Support the review, routing, and processing of controlled documents and quality system records.
- Participate in investigations of nonconformances, deviations, and audit observations by gathering data and supporting root cause analysis activities.
- Assist with preparation for internal audits, customer audits, and regulatory inspections.
- Generate and maintain quality system metrics and reports to support management review activities.
- Collaborate with Manufacturing, Engineering, Quality Assurance, Regulatory Affairs, and Operations personnel to ensure consistent application of quality system requirements.
- Identify opportunities for process improvements and standardization within quality system processes.
- Support implementation of new or revised corporate quality system procedures across multiple sites.
- Maintain a working knowledge of applicable regulatory requirements and internal procedures necessary to perform assigned responsibilities.
- Other duties as assigned.
Qualifications
- Bachelor’s degree or equivalent experience
- Minimum 2 years of experience in a regulated manufacturing environment, preferably within the medical device area
- Working knowledge of Quality Management System (QM) principles and regulatory requirements
- Familiarity with electronic quality systems and document management systems
- Strong organizational and documentation skills
- Effective written and verbal communication skills
- Strong attention to detail and commitment to compliance
