Quality Engineer

For a cutting-edge medical device company, we are seeking an experienced, motivated Quality Engineer to join our team.

Main Responsibilities:

• Primary Responsibilities in Production
• Monitor in-process quality controls and production line inspections, including incoming, in-process and finish goods quality controls.
• Monitor production-related non-conformities and corrective actions
• Review production documentation (DHRs) for accuracy and compliance
• Oversee production manufacturing activities (including production in cleanroom)
• Oversee acceptance, performance and routine maintenance of equipment calibration and maintenance activities Additional QA Support
• Support quality records and activities follow-up, including CAPAs and MRB/NCR
• Support supplier qualification and evaluation
• Support training/qualification and competency activities with follow-up
• Assist with internal and external audits
• Manage document control activities
• Provide QA support to other departments/employees

Experience :

Bachelor’s degree in science or engineering (Mechanical, Biomedical, or related)

Minimum 3 years' experience as quality engineer/QC activities in medical device industry (ISO 13485, FDA QMSR, MDR) Skills

Strong communication and teamwork abilities

Excellent technical comprehension

Proficient in English (reading and writing)

Proficient in standard MS Office applications

Strong communication and teamwork abilities

Excellent technical comprehension

Proficient in standard MS Office applications