Quality Engineer

A company is looking for a Quality Engineer to ensure compliance with medical device regulations and global standards.

Key Responsibilities

Support design control activities and ensure compliance with regulatory requirements

Participate in risk management activities and conduct root cause investigations

Maintain and improve the Quality Management System in compliance with relevant regulations

Required Qualifications

Bachelor's degree in Engineering, Biomedical Engineering, Mechanical Engineering, or a related scientific discipline

Experience in a regulated medical device environment with knowledge of FDA QSR and ISO standards

Hands-on experience in process validation, CAPA, and audit support

Familiarity with statistical analysis tools for data-driven decision-making

Certification in Lean Six Sigma or a similar credential preferred