Quality Systems Specialist

Turbett Surgical is seeking a detail-oriented, collaborative, and highly motivated Quality Systems Specialist to support and maintain the company's Quality Management System (QMS). Reporting to the VP Quality, Regulatory & Compliance, this role will play a critical part in ensuring compliance with applicable regulatory requirements, quality standards, and internal procedures while supporting continuous improvement initiatives across the organization.

The Quality Systems Specialist will be responsible for administering key quality system processes, including document control, training management, corrective and preventive actions (CAPA), change control, complaints management, quality plans, QMS software validation, audit support, and associated quality records. This individual will work closely with Quality Assurance, Quality Control, Regulatory Affairs, Operations, and Engineering teams to ensure product quality, patient safety, and regulatory compliance.

The successful candidate will possess strong organizational and analytical skills, experience working within a regulated medical device environment, and a commitment to maintaining the highest standards of quality and compliance. Experience utilizing electronic quality management systems, including Grand Avenue Software, is highly desirable.

• Maintain and support the company's Quality Management System (QMS) in accordance with FDA Quality System Regulations, ISO 13485, and other applicable standards.
• Manage controlled documents, records, forms, and procedures through established document control processes.
• Support training program administration, including training assignments, records maintenance, and effectiveness monitoring.
• Coordinate periodic review and revision of quality system procedures and work instructions.
• Support Management Review activities through data collection, metric reporting, and maintenance of quality records.

• Administer Corrective and Preventive Action (CAPA) processes, ensuring timely investigations, root cause analyses, action implementation, and effectiveness verification.
• Assist in the management of Nonconformance Reports (NCRs) and quality investigations.
• Facilitate change control activities and ensure appropriate assessments, approvals, and implementation documentation are completed.
• Support risk management activities associated with quality system changes and product quality issues.

• Support the complaint handling process, including intake, documentation, investigation coordination, and closure activities.
• Ensure customer complaints are processed in compliance with applicable regulatory requirements and internal procedures.
• Collaborate with Regulatory Affairs, Operations, Engineering, Quality Assurance, and Quality Control teams during complaint investigations.
• Analyze complaint trends and support the identification of recurring issues requiring CAPA or process improvements.
• Maintain accurate complaint records and support complaint-related reporting activities.

• Assist with internal audits, supplier audits, and external regulatory inspections.
• Participate in audit preparation activities and support responses to audit observations.
• Monitor compliance with internal procedures, quality system requirements, and regulatory expectations.
• Support inspection readiness initiatives across the organization.

• Compile, analyze, and report quality system metrics and performance indicators.
• Monitor trends related to complaints, CAPAs, nonconformances, audits, and training compliance.
• Identify opportunities for process improvements and assist with implementation of…