About the Role:The Complaint Investigations Engineer (QE) will be a key member of Modular Medical's Quality team, responsible for supporting post-market complaint handling activities. This role will work cross-functionally with Quality, Regulatory Affairs, Engineering, Manufacturing, and other departments to ensure complaints are appropriately evaluated, investigated, documented, and closed in accordance with applicable regulatory requirements and company procedures.
The Engineer will support the complaint management process from initial intake and data review through investigation, root cause analysis, Medical Device Reporting (MDR) assessment, trending, and final closure. The role will also identify recurring product quality issues, evaluate potential product and patient safety risks, and drive continuous improvement through effective complaint investigations and corrective and preventive actions (CAPA).
Minimum Qualifications:- Bachelor's degree in engineering, or another technical discipline, or an equivalent combination of education and experience.
- Minimum of 5 years of experience in an FDA-regulated environment, preferably within the medical device industry.
- Experience with medical device complaint handling, quality investigations, or post-market quality activities.
- Working knowledge of FDA regulations, ISO 13485, and applicable medical device quality system requirements.
- Understanding of Medical Device Reporting (MDR) requirements and complaint reportability assessments.
- Experience conducting investigations and applying root cause analysis methodologies.
- Experience with quality systems, nonconformances, CAPA, and quality documentation.
- Ability to analyze quality data, identify trends, and recognize potential product quality issues.
- Strong technical writing, and problem-solving skills, with the ability to prepare clear well-supported investigation reports.
- Ability to work independently under minimal supervision.
- Ability to manage multiple investigations and competing priorities while meeting established deadlines.
- Strong organizational skills and attention to detail.
Preferred Qualifications:- Experience investigating complaints involving medical devices, insulin pumps, or other diabetes-related products.
- Experience evaluating medical device malfunctions, product performance issues, and potential patient safety concerns.
- Experience with FDA MDR assessments and reporting requirements.
- Experience with complaint trending, quality metrics, and establishing alert and action limits.
- Experience with electronic Quality Management Systems (eQMS) and complaint management software platforms (I.e. Salesforce, Trackwise).
- Experience supporting CAPA investigations.
- Familiarity with risk management principles and standards applicable to medical devices.
- Experience supporting internal and external regulatory audits.
Responsibilities:- Manage post-market complaint investigations ensuring accurate documentation, timely completion, and compliance with regulatory requirements.
- Conduct technical investigations of medical device complaints, including review of device history records, returned product evaluations, device logs, and other failure mechanisms.
- Perform root cause analysis, evaluate product performance issues, assess potential patient safety risks, and document investigation findings and conclusions.
- Evaluate complaints for Medical Device Reporting (MDR) requirements to ensure appropriate reportability assessments, escalation, and regulatory timelines.
- Analyze and trend complaint data to identify recurring issues, emerging product quality concerns, and opportunities for CAPA and continuous improvement.
- Collaborate cross-functionally with Quality, Engineering, Manufacturing, and Regulatory Affairs to drive investigation activities, implement corrective actions, improve product reliability, and ensure timely complaint resolution
Skills:- Knowledge of medical device complaint handling processes, including complaint intake, triage, investigation coordination, documentation, and timely closure.
- Proficiency in investigation methodologies such as 5 Whys, fault tree analysis, and other structured problem-solving techniques.
- Working knowledge of FDA medical device regulations, Medical Device Reporting (MDR), ISO 13485, and applicable quality system requirements.
- Ability to analyze complaint data, identify recurring failure modes, establish quality metrics, and recognize trends requiring further investigation or CAPA.
- Understanding of product risk evaluation, and patient safety considerations.
- Experience with electronic Quality Management Systems (eQMS), complaint management platforms, investigation reports, and maintaining accurate records.
- Ability to work effectively with Engineering, Manufacturing, Quality, and Regulatory Affairs to coordinate investigations, communicate technical findings, and drive issue resolution.
