Quality System Specialist

Join Vital Path in Maplewood as a Quality Systems Specialist!

Vital Path is a trusted contract manufacturing partner that delivers high-quality complex catheter solutions around the world that save lives and restore patient health and vital function. We strive to treat every product we design and manufacture to the highest level of quality and awareness that these products are going to be used inside of a patient, possibly even our own family members.

Our employees impassioned hard work and dedication are at the core of our success. Every function within our organization plays a crucial role in our mission and is deeply valued for its contribution to achieving our shared goals of quality, innovation, continuous improvement, and operational excellence.

As a fast-growing organization, we bring harmony and standardization across Vital Path with a strong vision in mind - We are one Vital Path. We embrace our diversity, celebrate each others success, support one another through change, and continue to grow as a high-performing organization. We aim to shape our corporate culture to enhance team member engagement, skills, and productivity so that Vital Path is an employer of choice.

If you’re ready to contribute to groundbreaking medical advancements in a collaborative, fast paced environment, we invite you to apply and be part of our growth!

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.

• This position requires the employee to be onsite at our Vital Path MN location.
• Shift/
  
  Schedule:
  
  Monday Thursday 9 hour days, Friday 4 hour day
• Vital Path does not offer relocation assistance for this position.

• 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.

• 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…