KH
Senior Medical Device Quality & Compliance Engineer
Katalyst Healthcares & Life Sciences
🇺🇸 United States
On-site
Senior
2 months ago
- Regulatory Compliance
- Risk Management
- CAPA
- FMEA
2 months ago
- 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.
- 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.
- 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.
Senior Medical Device Quality & Compliance Engineer · Katalyst Healthcares & Life Sciences