The Quality Engineer will provide quality oversight for new product development, sustaining engineering changes, risk management activities, and maintenance of Design History File (DHF) documentation while ensuring compliance with applicable regulations and standards.
Ensure compliance with Design Control requirements and internal procedures.
Review and monitor of design planning, design reviews, design V&V, and design transfer activities for compliance.
Ensure traceability between user requirements, design inputs, design outputs, risk controls, V&V activities.
Review and approve ECOs, ECRs for risk, and compliance with QMS and standards.
Verify that changes are properly documented, approved, implemented, and closed according to established procedures.
Requirements
Bachelor's degree in Engineering, Biomedical Engineering, Mechanical Engineering, Quality Engineering, or related technical/medical discipline.
At least 5 years of Quality Engineering experience in the medical device industry.
Experience with relevant standards (ISO13485, ISO 14971).
Experience supporting Design Control and Change Control processes.
Experience reviewing DHF, DMR, V&V protocols and reports, and other technical documentation.
Fluent English (written and spoken).
Proficiency in MS-OFFICE
Nice to have
Certified Quality Engineer (CQE) or equivalent certification