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Quality Assurance Supervisor

Phase Scientific International Limited

  • Company Industries:Medical/Pharmaceutical

Job Information

  • Post Date:2022-06-16
  • Career Level:Middle
  • Location:Kwun Tong
  • Yr(s) of Exp:5 years
  • Qualification:Degree
  • Employment Type:Full Time, Permanent
  • Job Function:Sciences  Lab  R&D  Life Science  Manufacturing  Manufacturing Management 
  • Benefits:Medical insurance, Performance bonus, Five-day work week

Job Description

Job Description

  • Develop, document and maintain the Quality system for compliance with ISO 9001, ISO 13485 and others to achieve "always audit-ready" level of conformity;
  • Actively champion and train teams to support the generation of records and evidence as a culture across the company
  • Through the existing changes and CAPA processes are continuously optimized to better meet the quality of cell therapy products Management characteristics;
  • Lead and conduct an on-site audit on critical suppliers and assess new potential suppliers
  • Lead and manage customer inquiries, incidents investigation, complaint follow-up, and root cause analysis to ensure problems can be timely solved, low risk to stakeholders, and meeting both management & customer expectation.
  • Lead continuous improvement by control of corrective actions and prevention 
  • Work with operating staffs to establish procedures, validations and specifications.

Job Specifications

  • University degree in related Biomedical Sciences or equivalent
  • Minimum 5 years’ experience in Quality Management field in which 2 years of them are in Supervisory experience and preferably in medical device manufacturing.
  • Strong knowledge of ISO 13485 system and FDA QSR with proven track record.
  • Excellent quantitative, analytical and problem-solving skills.
  • Proficient in both written and spoken Chinese and English
  • Knowledge of IVD device is definitely an advantage

 We offer an attractive basic salary, 5-day work, on-the-job training and career advancement opportunity to the right candidates.  Please send full resume with availability, current and expected salary by clicking "Apply Now

 Benefits

  •          Five-day work
  •          Bank Holidays
  •          Medical Insurance
  •          12+ Days Annual leave
  •          Paid Marriage Leave
  •          Birthday Leave

 (Personal data collected will be used for recruitment purpose only.)

Company Info

PHASE Scientific is a high-growth biotech company with a mission to inspire a new state of health. Founded and led by Dr. Ricky Chiu, UCLA-trained bioengineer, Adjunct Associate Professor at CUHK and Outstanding Young Persons of Hong Kong, PHASE Scientific has a team of 200 across Hong Kong, Shenzhen and Southern California. We provide novel diagnostic tools and services for cancer and infectious diseases with our proprietary technologies.

PHASE Scientific has been a pivotal force in supporting the fight against COVID-19 through its full range of testing products and services (PCR community testing, INDICAID rapid test kits and INDICAID lab testing services). To date, PHASE has conducted over 3 million PCR tests and sold over 30 million INDICAID rapid test kits in over 30 countries.

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