Our company, which has been established for several decades, is specialized in design, manufacturing and distribution of Medical Devices.
With continuous expansion of business, a new structure will emerge in our offices in Hong Kong in order to market new products.
Regulatory and Quality Assurance Engineer/Manager
|Work exp||Minimum 3 Years|
|Language||Chinese - Mandarin, English|
|Employment type||Full Time|
|Benefits||13-month pay, 5-day week, MPF, Medical plan|
|Industry||Medical services / Pharmaceutical|
Quality Control / Quality Assurance > ISO, International Organization of Standardization
Quality Control / Quality Assurance > Quality Control & Assurance
In order to set up a complete Quality System and get certification ISO 13485, we are looking for a Regulatory and Quality Assurance Engineer / Manager
- Set up the quality assurance systems and obtain the certification ISO 13485.
- Create, implement and improve quality systems to achieve quality goals.
- Monitor the quality performance of factory operations and suppliers.
- Identify production quality problems and implement improvement plans.
- Responsible for maintaining GMP requirements and product registration.
- Also in the continuity of his work, the candidate will present to the local Notified Body the technical files issued by the parent company and the R&D department, both based in Europe, in order to obtain certifications CE, SFDA...
- Degree holder in Quality Management / Manufacturing Engineering or related discipline.
- Minimum 3 years of working experience in manufacturing industry, ideally in Medical Devices industry.
- Strong knowledge of management systems such as ISO13485 and regulations regarding Medical Devices Class I, IIa and IIb.
- Strong leadership, detail-oriented with good analytical and problem solving skills.
- Fluent written and spoken English.