Quality Systems Specialist - Remote

Overview

This role is responsible for ensuring quality management systems (QMS) in line with corporate standards and regulatory requirements. This role may design, prepare, and maintain data reports and metrics to support compliance and trend quality issues.

In Short

• Ensure compliance of site QMS with corporate standards.
• Prepare and maintain documentation related to quality management processes.
• Conduct analysis to assess QMS effectiveness.
• Collaborate with teams to implement corrective and preventive actions.
• Monitor and analyze quality performance metrics.
• Provide training on quality management principles.
• Support eDHR creation and maintenance.
• Assist with external audits.
• Work independently and in teams.
• Ensure CAPAs are not past due.

Requirements

• High School Diploma or GED.
• Knowledge of ISO 13485 and FDA regulations preferred.
• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal skills.
• Working knowledge of TrackWise and SAP.
• Proficiency in quality management software.
• Ability to work independently and collaboratively.

Benefits

• Supportive work environment for learning and growth.
• Opportunity to contribute to meaningful health solutions.
• Culture that values opinions and contributions.
• Flexibility and work-life balance.
• Commitment to employee development.