Quality Operations Specialist

We are seeking a highly motivated Quality Operations Specialist to support quality and compliance activities within a regulated medical device environment. This role will be responsible for investigating customer complaints, performing technical troubleshooting of returned devices, supporting manufacturing quality initiatives, and ensuring compliance with FDA, ISO 13485, and other applicable regulatory requirements.

The ideal candidate will have experience in medical device quality systems, complaint handling, root cause investigations, CAPA activities, and product troubleshooting.

Key Responsibilities

• Review, evaluate, and investigate technical and clinical customer complaints in accordance with established procedures and timelines.
• Perform hands-on troubleshooting and failure analysis of customer-returned devices and manufacturing nonconformities.
• Document investigation findings and maintain accurate complaint files and quality records.
• Support quality functions related to production, manufacturing line support, and SAP-based quality processes.
• Assist complaint intake teams by reviewing and verifying complaint coding and documentation accuracy.
• Monitor and analyze product performance through complaint trending, service data, and manufacturing rejection analysis.
• Conduct root cause investigations and support implementation of corrective and preventive actions (CAPA).
• Collaborate cross-functionally with Quality, Manufacturing, R&D, Supply Chain, Regulatory, and other teams to drive product and process improvements.
• Support post-market surveillance activities and regulatory reporting requirements.
• Ensure compliance with Quality Management System (QMS) requirements and applicable regulations including FDA, ISO 13485, and global medical device standards.
• Participate in audits, inspections, and quality improvement initiatives.

Required Qualifications

• Bachelor's Degree in Engineering or Natural Sciences.
• 2-5 years of experience in Quality, Complaint Handling, Quality Engineering, Post-Market Surveillance, or related medical device quality functions.
• Experience investigating customer complaints and product quality issues.
• Knowledge of medical device quality systems and documentation requirements.
• Experience with root cause analysis, failure investigations, CAPA, and nonconformance management.
• Strong written and verbal communication skills.
• Proficiency in Microsoft Excel and other computer applications.