Onsite Quality Systems Specialist - Medical Devices

VitalPath; Minnesota; On-site; USD 70,000 - 82,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

401K with company match

Paid time off

Job summary

VitalPath seeks a Quality Systems Specialist to support the execution and maintenance of a harmonized quality management system across multiple manufacturing sites in a regulated medical device environment.

You will coordinate document control, training compliance, CAPA coordination, change control administration, and audit readiness activities, partnering with cross-functional teams to ensure compliance with FDA, ISO 13485 and internal requirements.

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.

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.
• Assist with 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.

Skills

QM principles

Regulatory compliance

Documentation skills

Communication skills

Education

Bachelor’s degree or equivalent experience

Tools

QMS software

Document management systems

Job description

VitalPath seeks a Quality Systems Specialist to support the execution and maintenance of a harmonized quality management system across multiple manufacturing sites in a regulated medical device environment.

You will coordinate document control, training compliance, CAPA coordination, change control administration, and audit readiness activities, partnering with cross-functional teams to ensure compliance with FDA, ISO 13485 and internal requirements.