Quality Engineer

About the role

Drive product quality and patient safety through data-driven problem solving. We are seeking a Quality Engineer to lead post-market surveillance activities for innovative medical devices, ensuring product performance, reliability, and compliance throughout the product lifecycle.

Responsibilities

• Lead complaint handling and product reporting investigations from intake through closure, including risk assessment, root cause determination, and product disposition.
• Manage returned product evaluations and failure analyses to identify quality trends and product performance opportunities.
• Investigate complex product issues and coordinate testing with internal teams and external laboratories when needed.
• Analyze field performance, customer complaints, and returned product data to identify emerging quality concerns.
• Lead cross-functional reviews with Development, Manufacturing, Operations, and Quality teams to drive corrective actions and continuous improvement.
• Support CAPA activities, risk assessments, and product reliability initiatives.
• Participate in post-market risk management reviews, product performance reviews, and safety evaluations.
• Generate, review, and maintain quality system documentation, including design history file (DHF), device master record (DMR), and engineering change documentation.
• Ensure compliance with FDA regulations, ISO standards, and applicable medical device requirements.
• Support internal and external audits and provide quality expertise across the organization.

Requirements

• 2+ years of experience in Quality Engineering, Design Quality, or a related medical device quality function.
• Experience with complaint handling, post-market surveillance, and field performance monitoring.
• Hands-on experience leading root cause investigations and failure analysis activities.
• Knowledge of medical device risk management methodologies, including dFMEA, pFMEA, and ISO 14971.
• Understanding of FDA Quality System Regulations and ISO quality standards.
• Strong analytical, problem-solving, and decision-making skills.
• Ability to manage multiple priorities and work independently in a fast-paced environment.
• Proficiency with Microsoft Office applications, including Excel, Word, and PowerPoint.
• Strong communication and collaboration skills with cross-functional teams.

Preferred Qualifications

• Experience with electromechanical or active implantable medical devices.
• Work history in product reliability, design quality, or process quality engineering.
• Familiarity with Class III medical devices.
• ASQ certifications such as CQE, CRE, CQA, or CQM.
• ISO auditor training or internal auditing experience.
• Knowledge of IEC, EN, and other medical device-related standards.
• Experience supporting CAPA systems, post-market risk reviews, and global regulatory requirements.