Quality Engineer

Overview

Quality Engineer (Complaints & Investigations) - We are seeking a Quality Engineer to support complaint handling, technical investigations, and failure analysis within a regulated medical device environment. This role is highly cross-functional, working closely with Customer Service, Engineering, Manufacturing, Regulatory, and Clinical teams to ensure timely and compliant resolution of technical issues. The ideal candidate will bring strong problem-solving skills, knowledge of medical device regulations, and the ability to communicate complex technical findings in a clear, concise way.

Responsibilities

• Troubleshoot escalated cases from Customer Service and provide timely feedback to internal stakeholders.
• Support complaint processing and closure by gathering data, conducting investigations, and documenting findings.
• Perform or coordinate failure analysis of returned devices and potential field issues using testing, lab processes, and data analysis.
• Collaborate with Engineering, Quality, and other investigation teams to identify root cause and corrective actions.
• Maintain compliance with FDA, ISO, and EU MDR requirements throughout the complaint handling process.
• Prepare documentation that translates technical investigations into clear reports understandable by non-technical reviewers.
• Support internal and external audits related to complaint handling activities.
• Stay current with evolving global regulatory standards impacting complaint handling and post-market quality.

Qualifications

• Bachelor’s degree in Engineering or a Scientific discipline (preferred).
• 1–2 years of experience in medical device complaint handling, quality engineering, or related technical support.
• Familiarity with regulations and standards including 21 CFR 820, 21 CFR 803, ISO 13485, ISO 14971, and EU MDR 2017/745.
• Experience working in a GMP and/or ISO-regulated environment.
• Strong technical writing skills, with the ability to translate investigations into clear documentation.
• Proficiency with MS Office (Outlook, Word, Excel, PowerPoint); experience with complaint handling or quality system databases a plus.
• Strong problem-solving and troubleshooting skills, with the ability to manage multiple cases simultaneously.
• Ability to work effectively in a cross-functional team environment.

Details

• Seniority level: Associate
• Employment type: Full-time
• Job function: Quality Assurance
• Industries: Medical Equipment Manufacturing