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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.

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

Job level Senior
Work exp Minimum 3 Years
Education Master Degree
Language Chinese - Mandarin, English
Location Causeway Bay
Employment type Full Time
Benefits 13-month pay, 5-day week, MPF, Medical plan
Industry Medical services / Pharmaceutical
Job function Quality Control / Quality Assurance > ISO, International Organization of Standardization
Quality Control / Quality Assurance > Quality Control & Assurance
Published On 29/11/2016
ref. QA20161115

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

 

Job Responsibilities:

  • 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... 

 Requirements:

  • 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.