Keyholder of Quality Standards
1 week ago
As a Quality Assurance professional, you will play a critical role in ensuring our company meets international standards. You will monitor and report on the effectiveness of our quality management system, promoting awareness of new regulations and standards.
You will oversee document control, engineering change control, and records control processes, evaluating suppliers and maintaining an approved supplier list. Your responsibilities will also include managing internal audits and calibration programs to ensure timely execution.
In addition, you will participate in design control, risk management, software development activities, and validation of analytical test methods, computer software, and production processes. You will handle non-conforming products, including investigation, corrective/preventive actions, and disposition.
Qualifications:
- Bachelor of Science degree in a scientific or engineering discipline
- Minimum 3 years of quality management system experience in the medical device industry
- Direct experience in design and development, risk management of medical device products is strongly preferred
Strong verbal and written communication skills, conversational Mandarin preferred. Strong analytical, time management, and organizational skills required. Proficient in MS Office applications.
A positive, proactive attitude with a willingness to learn is essential.
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