Senior Medical Device Quality & Compliance Engineer

Job Summary:

• 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)
  • pplication, Process, Design, and System FMEA
• Experience with:
  • Design of Experiments (DOE)
  • Reliability Prediction and Statistical Analysis
  • dvanced Descriptive and Non-Parametric Statistics
  • Root Cause Analysis and Continuous Improvement
• Strong project planning and execution skills.
• bility 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.