Quality Engineer

Job Summary

Quality Engineer with mandatory experience in the medical devices domain responsible for planning and executing validation activities aligned with ISO and ISO , overseeing daily project operations at the client location, and supporting R&D new product development, design change management, product lifecycle management, risk management, and design verification & validation activities.

• Plan and execute validation activities in alignment with ISO and ISO .
• Manage and oversee daily operations and projects at the client location as the primary link between client and project team.
• Lead and support design verification and validation activities, including test method development and execution.
• Perform sample size selection and statistical data analysis to support design decisions and risk assessments.
• Conduct process capability studies and support design transfer to manufacturing.
• Ensure compliance with FDA, ISO , and other relevant regulatory standards.
• Collaborate with cross-functional teams including R&D, Regulatory, and Manufacturing.
• Review and approve design documentation including DHF, risk management files, and test protocols.
• Provide technical guidance and mentorship to junior QEs offshore.
• Support CAPA investigations related to design issues and contribute to continuous improvement initiatives.
• Support product lifecycle management and design change management activities.

• Prior experience in the medical devices domain (mandatory).
• Experience in R&D new product development and design change management.
• Experience in product lifecycle management, risk management, and design verification & validation.
• Certified Quality Engineer (CQE) or equivalent certification.
• Experience with statistical analysis tools such as Minitab, JMP, or similar platforms.
• Familiarity with ISO risk management standards and IEC usability engineering.
• Good knowledge of Medical Devices & QMS standards (ISO , CFR Part ).