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Requirements:
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 Education and Experience:
*Bachelors 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 Skills:
*Strong communication and teamwork abilities
*Excellent technical comprehension