Quality Specialist

Position Summary

The Quality Specialist is responsible for supporting and administering key elements of the Quality Management System (QMS) to ensure compliance with applicable regulatory requirements and company procedures. This role will work independently to manage quality system processes, support continuous improvement activities, and help maintain compliance with FDA and international quality standards applicable to the medical device industry.

Key Responsibilities

• Administer and maintain various elements of the Quality Management System (QMS), including:
  • Corrective and Preventive Action (CAPA) system
  • Field Action system
  • Management Review
  • Nonconformance system
  • Additional quality system processes as assigned
• Ensure quality records and documentation are complete, accurate, and compliant with internal procedures and regulatory requirements.
• Support investigations, root cause analysis, and follow-up activities related to quality issues and nonconformances.
• Monitor quality system activities and help ensure timely completion of assigned tasks.
• Assist with internal audits, external audits, and regulatory inspections as needed.
• Collaborate cross-functionally with internal departments to support quality and compliance objectives.
• Identify opportunities for process improvement and support implementation of corrective actions.
• Maintain compliance with FDA 21 CFR Part 820, QMSR, ISO 13485, and applicable company procedures.

Qualifications

• 1–3 years of experience in the medical device industry required.
• Experience working with software applications, electronic quality systems, and database-driven tools required.
• Experience creating, maintaining, and managing databases, logs, trackers, or similar quality system records required.
• Experience working within a Quality Management System (QMS) environment required.
• Familiarity with FDA 21 CFR Part 820 and Quality Management System Regulation (QMSR) requirements required.
• Experience with ISO 13485 preferred.
• Ability to manage tasks and quality system activities independently with minimal supervision.
• Strong organizational skills and attention to detail.
• Effective written and verbal communication skills.
• Proficiency with Microsoft Office and electronic quality systems preferred.

Salary : $50,000 - $60,000