We are looking for a Quality Engineer to join our medical device team. In this role, you will help ensure our products and manufacturing processes meet quality and regulatory standards while supporting continuous improvement initiatives.
Responsibilities
Maintain and improve the Quality Management System (QMS).
Support CAPA, nonconformance, complaint investigations, and root cause analysis.
Ensure compliance with ISO 13485, FDA regulations, and GMP.
Assist with process validation, risk management, and change control.
Support internal, supplier, and regulatory audits.
Collaborate with Engineering, Manufacturing, and Regulatory teams to improve product quality.
Qualifications
Bachelor's degree in Engineering or a related field.
3+ years of Quality Engineering experience in the medical device industry.
Knowledge of ISO 13485, FDA Quality System Regulations, CAPA, and validation.
Robust problem-solving and communication skills.