Quality Engineer

Job Summary:

Quality Engineer with mandatory experience in the medical devices domain responsible for planning and executing validation activities aligned with ISO 13485 and ISO 14971, 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 13485 and ISO 14971.
• 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 13485, 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 14971 risk management standards and IEC 62366 usability engineering.
• Good knowledge of Medical Devices & QMS standards (ISO 13485, 21 CFR Part 820).