Quality Systems Specialist

Position Summary

The Quality Systems Specialist is responsible for supporting, maintaining, and continuously improving the Quality Management System (QMS). This role ensures compliance with FDA Quality System Regulation (QMSR, 21 CFR Part 820) and ISO 13485:2016 and supports quality activities for Class I medical devices, with future scalability to Class II products.

This is a hands-on role requiring active participation in quality system administration, audits, CAPA, supplier quality, complaints, and regulatory compliance activities.

Key Responsibilities

• Maintain and improve the ISO 13485-compliant Quality Management System.
• Manage document control, record retention, and training records.
• Support supplier qualification, supplier audits, and Approved Supplier List maintenance.
• Maintain Design History Files (DHF), change controls, and quality records.
• Support risk management activities in accordance with ISO 14971.
• Assist with process validation activities (IQ/OQ/PQ).
• Review and investigate nonconformances and support CAPA activities.
• Manage complaint handling, product returns, and post-market quality activities.
• Participate in internal audits and support FDA and ISO inspections.
• Prepare quality metrics, audit summaries, and management review inputs.
• Promote quality system compliance and continuous improvement across the organization.

Required Qualifications

Education

• Bachelor’s degree in Engineering, Life Sciences, Quality, or related scientific discipline preferred.

Experience

• 5+ years of quality experience in the medical device industry.
• Experience supporting an ISO 13485 Quality Management System.
• Experience with CAPA, complaint handling, supplier quality, audits, and document control.
• Experience supporting FDA inspections and/or ISO certification audits preferred.
• Small-company or startup medical device experience preferred.

Knowledge & Skills

• Working knowledge of FDA QMSR and ISO 13485:2016.
• Familiarity with CAPA, supplier quality, validation, complaints, and risk management.
• Strong organizational, documentation, and communication skills.
• Ability to work independently in a fast-paced environment.