QA Engineer

Responsibilities:

• Ensure adherence to ISO 13485 standards for the Quality Management System.
• Execute inspections of incoming materials and work in progress.
• Examine and verify documentation.
• Assist in the release of engineering drawings.
• Monitor and track quality record issues, including non-compliance.
• Contribute to supplier approval and assessment.
• Manage change control and Engineering Change Order (ECO) processes.
• Facilitate training, qualification, and competency tracking.
• Support quality-related processes for Verification & Validation (V&V).
• Oversee equipment calibration and maintenance.
• Monitor clean room and production manufacturing operations.
• Participate in internal and external audits.
• Create and maintain quality system documentation.
• Provide quality assurance support to other departments.

Reports To: Director of QA

Qualifications:

• Bachelor’s degree in science, mechanical, or biomedical engineering.
• Minimum three years of experience in quality engineering, document control, or Quality Management System (QMS) activities within the medical device sector (ISO 13485 and/or FDA QSR).

Skills:

• Effective interpersonal and collaborative abilities.
• Strong grasp of technical concepts.
• Fluency in written and verbal English.
• Competency in standard Microsoft Office applications.