Quality Engineers

Product Quality Engineer – Investigations Location: Remote Duration: 12-Month Contract Job SummaryWe are seeking Product Quality Engineers to support post-market complaint investigations for complex medical devices, including implantable cardiac devices, defibrillators, and pacemakers. This role is responsible for reviewing complaint investigations, performing device failure analysis, conducting risk assessments, and completing final investigation reviews to ensure compliance with quality and regulatory requirements.The ideal candidate will have a strong engineering background with experience evaluating hardware and software-related medical device failures, applying risk-based decision-making, and supporting post-market quality activities. This is an assessment-focused role with no hands-on laboratory testing. Key ResponsibilitiesReview and evaluate complaint investigations for complex medical devices.Perform device failure analysis and determine root cause and appropriate investigation conclusions.Conduct final review and approval of complaint investigations for accuracy, completeness, and regulatory compliance.Assess hardware and software-related product failures and evaluate potential patient and product impact.Perform hazard analysis and risk assessments to support product quality investigations.Collaborate with cross-functional investigation and trending teams to interpret failure analysis results.Support post-market surveillance activities and maintain compliance with Quality Management System (QMS) requirements.Apply engineering principles and analytical problem-solving techniques to resolve complex product quality issues.Ensure investigation documentation complies with FDA, ISO 13485, and internal quality standards.Support continuous improvement initiatives related to complaint handling and product quality. Required QualificationsBachelor's degree in Engineering (Electrical, Biomedical, Mechanical, or related discipline).Experience with medical device complaint investigations and complaint handling processes.Strong experience performing device failure analysis.Experience conducting hazard analysis and risk assessments.Knowledge of hardware and software-driven medical devices.Ability to evaluate technical data and make risk-based quality decisions.Strong analytical, documentation, technical writing, and problem-solving skills.Experience working within a regulated FDA and ISO 13485 medical device environment. Preferred QualificationsBachelor's degree in Electrical Engineering.Experience investigating electrical failures, PCBAs, electronic components, circuits, or embedded systems.Experience supporting implantable medical devices, cardiac rhythm management (CRM) devices, pacemakers, or implantable cardioverter defibrillators (ICDs).Knowledge of post-market surveillance, product quality engineering, and medical device regulatory requirements.Familiarity with risk management methodologies (ISO 14971) and complaint investigation best practices.