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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