Shift Timing - 11:00 AM - 8:00 PM
How You'll Create Impact
Complaint & Event Investigation
Conduct thorough investigations of complaints, nonconformances, and adverse events
Determine root cause, contributing factors, and device performance impact
Evaluate investigation data including complaint records, service data, manufacturing history, and design documentation
Ensure investigations are completed accurately, thoroughly, and within required timelines
FDA Regulatory Compliance
Perform investigations in accordance with 21 CFR Part 820 (Quality System Regulation)
Support 21 CFR Part 803 (Medical Device Reporting – MDR) reportability assessments
Provide investigation outputs that support regulatory submissions and health authority inquiries
Ensure documentation meets FDA and internal quality expectations
Risk & Patient Safety Evaluation
Assess patient safety, clinical risk, and device performance impact of reported events
Link investigation outcomes to risk management activities per ISO 14971
Support updates to risk files, hazard analyses, and risk controls based on post-market findings
Cross-Functional Coordination
Collaborate with Quality, Regulatory Affairs, Manufacturing, R&D, Clinical, and Supplier Quality teams
Facilitate cross-functional reviews to align on investigation conclusions and next steps
Support escalation to CAPA, design changes, process improvements, or MDR reporting as required
Documentation & Inspection Readiness
Produce clear, complete, and traceable investigation records
Ensure documentation supports FDA inspections, internal audits, and management review
Clearly document conclusions, rationale, and decision-making related to safety and compliance
What Makes You Stand Out
Preferred Qualifications
4 to 6 years total experience in regulated medical device environments
Experience investigating serious injuries, malfunctions, or death-related events
Experience with robotic, software-driven, or capital medical equipment
Experience collaborating with Clinical or Medical Affairs teams
Quality or regulatory certifications (CQE, RAC, Six Sigma – preferred)
Core Competencies
Strong analytical and systems-thinking skills
High attention to detail and documentation rigor
Ability to make defensible, risk-based decisions
Clear communication with technical, clinical, and regulatory stakeholders
Strong ownership for patient safety and compliance outcomes
Your Background
Required Technical Skills
Experience in medical device systems engineering, quality engineering, or post-market surveillance
3+ years conducting complaint investigations or adverse event investigations in FDA-regulated environments
Demonstrated experience supporting FDA inspections or regulatory audits
Experience with complex electromechanical devices; robotic medical device experience preferred
Technologies & Tools
Quality & Investigation Systems
Electronic Quality Management Systems (eQMS) (e.g., TrackWise, ETQ, MasterControl)
Complaint handling and investigation workflows
NCR, CAPA, and deviation management systems
Risk Management & Analysis
ISO 14971 risk management frameworks
Hazard analysis, FMEA/FMECA, fault tree analysis (support level)
Root cause analysis tools (5 Whys, Fishbone/Ishikawa)
Regulatory & Standards
21 CFR Part 820 (QSR)
21 CFR Part 803 (Medical Device Reporting)
ISO 13485 (preferred)
Post-market surveillance and vigilance processes
Data & Documentation
Technical documentation systems (PLM, document control systems)
Data analysis tools (Excel – advanced; statistical tools preferred)
EOE/M/F/Vet/Disability
