Quality engineer

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 (Company) 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 action items.

Education

5+ years of experience in Medical Device Quality & Compliance, with strong knowledge of ISO 13485, 21 CFR 820, MDD/MDR.

Hands-on experience in: Quality Management Systems (QMS) Complaint Management Post Market Surveillance (PMS) Non-Conformance (NC) Corrective and Preventive Action (CAPA) Audits

Strong expertise in Risk Management (ISO 14971), including FMEA and data-driven quality decision-making.