Bachelor's degree in Engineering or a related technical field.
8+ years of experience in Medical Device Quality and Compliance.
Expertise in ISO 13485:2016/2019 and FDA 21 CFR Part 820.
Knowledge of Medical Device Directive (MDD) and Medical Device Regulation (MDR).
Proficient in Non-Conformance and CAPA Management.
Responsibilities
Lead design transfer and production support activities for compliance.
Manage quality activities across surgical robotics subassemblies.
Conduct investigations on Non-Conformances and implement CAPA.
Develop and keep updated Risk Management documentation and FMEAs.
Support resolution of manufacturing issues and process qualifications.
Enhance Quality Management System (QMS) procedures.
Aid in internal audits and regulatory inspections.
Benefits
Opportunities for continuous professional growth and development.
Dynamic work environment within a cutting-edge industry.
Collaborative team culture with cross-functional interactions.
Involvement in innovative surgical robotics projects.
Full Job Description
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.
