Quality engineer
Katalyst Healthcares and Life Sciences
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 (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.
- 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)
- udits
- Strong expertise in Risk Management (ISO 14971), including FMEA and data-driven quality decision-making.
Vacancy posted 1 day ago
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