Complaint Investigations Engineer

ADP, Inc.; San Diego (CA); On-site; USD 70,000 - 125,000; Full time

Job summary

ADP, Inc. is seeking a Complaint Investigations Engineer in San Diego to support post-market complaint handling within Modular Medical's Quality team. You will investigate, document, and close complaints and work across Quality, Regulatory Affairs, Engineering, and Manufacturing to ensure regulatory compliance.

The role involves data review, root cause analysis, MDR assessment, trending, and CAPA-driven continuous improvement while meeting timelines and quality standards.

Qualifications

• Bachelor's degree in engineering or a technical field.
• 5+ years in FDA-regulated environment, preferably medical devices.
• Experience with medical device complaint handling and investigations.
• Knowledge of FDA regulations, ISO 13485, and quality systems.
• Understanding MDR requirements and reportability.
• Experience with root cause analysis and CAPA.
• Experience with quality documentation and nonconformances.

Responsibilities

• Manage post-market complaint investigations with accurate documentation and regulatory compliance.
• Conduct technical investigations of medical device complaints using device history records and logs.
• Perform root cause analysis and evaluate product safety risks; document findings.
• Assess MDR requirements and ensure proper reportability and timelines.
• Analyze and trend complaint data to identify recurring issues and CAPA opportunities.
• Collaborate with Quality, Engineering, Manufacturing, and Regulatory Affairs to drive corrective actions.

Skills

Root cause analysis

Technical writing

Data analysis

Quality investigations

Cross-functional collaboration

Regulatory knowledge

MDR knowledge

Education

Bachelor's degree in engineering or related field

Tools

eQMS

Salesforce

Trackwise

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Complaint Investigations Engineer

2 days ago Requisition ID: 1096

Salary Range: $70,000.00 To $125,000.00 Annually

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.