Quality Specialist

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, and 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.
• Absorb and 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.

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.