Senior Quality Systems Engineer

MINIMUM QUALIFICATIONS

• Bachelor’s degree in Mechanical, Electrical, Biomedical Engineering, or related scientific discipline.
• 7+ years of experience in medical device, regulated industry, manufacturing engineering, quality engineering, or related technical role.
• Or Master’s degree in Mechanical, Electrical, Biomedical Engineering, or related scientific discipline with 5+ years of relevant industry experience.
• Strong working knowledge of medical device quality system and complaint handling requirements, including 21 CFR Part 820, 21 CFR Part 803 (MDR), and ISO 13485.
• Strong analytical and problem-solving skills with demonstrated ability to evaluate complex information, identify failure mechanisms, and develop technically supported conclusions.
• Strong technical writing skills with demonstrated ability to clearly and concisely document investigation methods, objective evidence, technical rationale, root cause conclusions, and supporting justification.
• Detail-oriented with strong organizational and time management skills.

• This position is responsible for, but not limited to, the following:
• Independently lead complaint investigations from intake through closure, ensuring timeliness, technical accuracy, and regulatory compliance.
• Perform hands-on troubleshooting, evaluation and failure analysis of returned devices and components, including mechanical, electrical, and system-level evaluation as applicable.
• Analyze device history records (DHRs), manufacturing records, service records, software logs, and field data to support root cause investigations.
• Apply structured root cause analysis methodologies (e.g., 5 Whys, Fishbone, fault tree analysis) to identify failure modes, root cause conclusions and contributing factors.
• Partner cross-functionally with Engineering, Manufacturing, Service, Clinical, and Regulatory teams to gather technical inputs and validate investigation conclusions.
• Clearly document investigation rationale, test methods, data analysis, conclusions, and justification for reportability determinations.
• Identify conditions requiring immediate or broader containment and work cross-functionally to ensure appropriate actions are initiated to mitigate potential risk in a timely manner
• Identify trends, recurring failure modes, or systemic risks and escalate through CAPA or other quality processes when warranted.
• Support evaluation of complaints for Medical Device Reporting (MDR), vigilance, and other regulatory reporting requirements under 21 CFR Part 803 and applicable global regulations.
• Assess risk implications using ISO 14971 principles and escalate potential systemic issues appropriately.
• Identify trends, recurring failure modes, or systemic risks and escalate through CAPA or other quality processes when warranted.
• Support internal audits, external audits, and regulatory inspections by providing technical expertise and clearly communicating investigation approaches, findings, conclusions, and associated follow-up actions.
• Maintain inspection-ready documentation in compliance with 21 CFR Part 820, ISO 13485, and internal procedures.
• Maintain working technical knowledge of company products, including system architecture, subsystems, and intended use.
• Perform other TransMedics tasks and duties as assigned/required