QA Engineer

Company Description

Aspect Imaging is a world leader in the design, development and manufacture of compact MRI and NMR Systems. Its unique, patented, high-performance permanent magnet technology platform enables its MRI systems to be placed and operated from almost anywhere without limitations.

One of our leading products is the Embrace Neonatal MRI System, the world’s first FDA cleared dedicated MRI installed inside the Neonatal Intensive Care Unit. https://embracemri.com/

Role Description

• Lead and maintain QMS implementation- CAPA, Complaints etc.

o   Manage CAPA and Complaints boards and make decisions regarding customer complaints and changes to the product design, write CAPA root cause investigations reports.

o   Perform statistical analysis for CAPA and complaint for management reviews.

o   Conducts internal audits, preparation for external audits and participation in external audits by regulatory bodies.

o   Preparation and participation in management review meetings.

• QA representative in risks evaluation for regulatory compliance.
• Ensure Quality Systems activities are implemented and maintained to satisfy FDA GMP/QSR, ISO 13485, MDR, MDSAP and applicable local regulatory requirements.

Requirements

• Minimum of bachelor’s degree is required.
• 2-5years of experience in a Quality / Regulatory function within the medical device company.
• Knowledge of applicable Quality System regulations, such as GMP/QSR, MDR and ISO 13485.
• Very good English skills (speaking, reading, and writing).

Personal Skills

o   Team Player

o   Strong communication

o   Organized and Detailed orientated