Senior Quality Engineer

Must Have Technical/Functional Skills

• Strong understanding of Medical Device Quality Systems and regulatory compliance requirements 

• Working knowledge of ISO 13485:2016/2019 and 21 CFR Part 820 (FDA Quality System Regulation) 

• Strong expertise in design transfer activities, including DHF → DMR transition and compliance with FDA 21 CFR 820 & ISO 13485

• Sound knowledge of Medical Device Regulations, including MDD and MDR 

• Proven experience in Non Conformance (NC) management, CAPA processes, and internal/external audits 

• Expertise in Medical Device Risk Management, with the ability to identify both apparent and less obvious risks 

• Practical experience with Application, Process, Design, and System FMEA methodologies 

• Proficient in statistical tools and techniques, including Design of Experiments (DOE) 

• Capable of performing advanced descriptive and non parametric statistical analyses 

• Experienced in leveraging advanced statistical methods for reliability prediction and data driven decision making

 

Roles & Responsibilities

• Lead design transfer and production support activities, ensuring compliance with FDA/ISO 13485 and alignment with manufacturing readiness. 

• Own multiple subassemblies for a surgical robotics platform, ensuring design integrity, quality, and manufacturability. 

• Investigate non-conformances (NCs) using root cause analysis and drive CAPA within the QMS framework. 

• Develop and maintain FMEAs, support risk mitigation, and lead manufacturing issue resolution and qualifications (IQ/OQ/PQ). 

• Identify and implement compliant, alternative solutions to engineering and production challenges while driving continuous improvement.

• Support and maintain Quality Management System (QMS) processes in compliance with regulatory requirements 

• Collaborate with cross functional teams to deliver quality compliant outcomes 

• Interpret and apply medical device regulations and standards to projects and processes 

• Support audits and regulatory inspections, ensuring timely closure of actions