Senior Medical Device Quality & Compliance Engineer

Senior Medical Device Quality & Compliance Engineer

Seeking a Senior Medical Device Quality & Compliance Engineer with expertise in Medical Device Quality Systems, Regulatory Compliance, Design Transfer, Risk Management, and Quality Engineering. The ideal candidate will support surgical robotics platforms, drive design transfer activities, manage quality processes, and ensure compliance with FDA and international medical device regulations.

Roles & Responsibilities:

• Lead design transfer and production support activities, ensuring manufacturing readiness and compliance with regulatory requirements.
• Own quality activities for multiple surgical robotics subassemblies, ensuring design integrity and manufacturability.
• Investigate Non-Conformances (Company) using root cause analysis and drive Corrective and Preventive Actions (CAPA).
• Develop and maintain Risk Management documentation and FMEAs.
• Support manufacturing issue resolution and process qualifications, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Maintain and improve Quality Management System (QMS) processes and procedures.
• Support internal and external audits, regulatory inspections, and timely closure of corrective actions.
• Collaborate with R&D, Manufacturing, Operations, Marketing, and Quality teams to deliver compliant solutions.
• Drive continuous improvement initiatives and data-driven quality decisions.

Education & Experience:

• Bachelor's degree in Engineering or a related technical field.
• 8+ years of experience in Medical Device Quality and Compliance.
• Strong expertise in:
  • ISO 13485:2016/2019
  • FDA 21 CFR Part 820 (Quality System Regulation)
  • Medical Device Directive (MDD) and Medical Device Regulation (MDR)
  • Design Transfer Activities (DHF to DMR Transition)
  • Quality Management Systems (QMS)
  • Non-Conformance (NC) and CAPA Management
  • Medical Device Risk Management (ISO 14971)
  • Application, Process, Design, and System FMEA
• Experience with:
  • Design of Experiments (DOE)
  • Reliability Prediction and Statistical Analysis
  • Advanced Descriptive and Non-Parametric Statistics
  • Root Cause Analysis and Continuous Improvement
• Strong project planning and execution skills.
• Ability to manage multiple projects and lead quality initiatives.
• Excellent stakeholder management, communication, and cross-functional collaboration skills.
• Experience determining outsourcing strategies based on capacity, complexity, and criticality.