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Design Quality Engineer (Medical Device)

GA Health Company Limited

  • Company Industries:Medical/Pharmaceutical

Job Information

  • Post Date:2020-04-04
  • Career Level:Middle
  • Location:Not Specified
  • Yr(s) of Exp:4 years
  • Qualification:Degree
  • Salary:Salary provided
  • Employment Type:Full Time
  • Job Function:Product Development / Management

Job Description

Job Summary

  • Report to the Quality Manager based in Hong Kong.
  • Deploy quality requirements to New Product Development (NPD) team to ensure the compliance of Medical QMS (ISO 13485), Regulatory (MDSAP, FDA, CE) and Customer Specific Requirements.
  • Support NPD team to ensure design specifications being delivered are adequate, accurate and practical for supplier, quality, manufacturing and relevant stakeholders.
  • Drive risk assessment in development phases per ISO14971, FMEA and due diligent approach to avoid and prevent recurrence of problems.
  • Participate design verification & validation and secure timely release of Design Quality Assurance (DQA) reports, Control Plan, MSA and First Article Inspection (FAI) for Materials/Part qualifications.
  • Lead or support factory’s engineers to develop and improve the quality control through appropriate statistical tools (strategic sampling plan, SPC, capability study … etc.) and development of validation protocol & process.
  • Conduct failure analysis on design & development or customer returned failure samples.

 

Job Requirements

  • Bachelor’s degree or above in Engineering or Science on technical field.
  • 5 years+ working experience in Quality, Engineering, Manufacturing or related technical functions.
  • 3 years+ working experience on development quality to ensure product’s safe launching and smooth transfer of new product to production.
  • Familiar with quality management systems (ISO 13485, CGMP), process control, statistical techniques and common quality tools such as CAPA, 8D, FMEA, MSA, SPC …etc.
  • Strong technical knowhow on silicon rubber, plastics, metals or molding and corresponding control and testing criteria, tools or standards.  
  • Experience in higher quality standards industry and criteria such as automotive, medical, pharmaceutical or good laboratory practice would be a plus.
  • Willing to travel in China (Guangdong, Suzhou) to support critical supplier/parts qualification or new product trial run around 2 weeks per month.
  • Good command of spoken and written English and Chinese (Cantonese and Mandarin).
  • Candidates with more experience will be considered as Senior Design Quality Engineer

Company Info

About GA Health Company Limited

GA Health is a wholly independent company with its headquarter in Hong Kong and manufacturing operations in China and Ireland. It has a distribution network which now stretches globally with a name built on quality, trust and integrity.

Our mission is to improve the quality of life through the design, development and manufacture of high quality, affordable medical product, for the benefit of patients and health professionals and with respect to our employees.

Andorate® is an emerging brand of disposable endoscopic accessories and devices manufactured by GA Health Company Limited. Our products are designed, developed and manufactured to reflect our ongoing commitment to patient safety, infection prevention and control.


Our vision is Healthcare without infection.

Our mission is To improve the quality of life through the design, development and manufacture of high quality, affordable medical product, for the benefit of patients and health professionals and with respect to our employees.

GA Health is embraced with strong values of integrity, fairness, quality, collaboration and partnership customer experience, simplicity.

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