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senior quality assurance manager (medical device) in Hong Kong

posted
contact
caleb wong, randstad hong kong
job type
permanent
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job details

posted
location
hong kong
specialism
sourcing & procurement
job type
permanent
working hours
Full-Time
reference number
91M0152843_1612267860
contact
caleb wong, randstad hong kong
apply now
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job description







about the company.Found in Hong Kong, our client is a growing medical device company with offices and factories in Hong Kong, China and Europe. With their own brand of dispensable endscopic devices, they are currently expanding their business and therefore would like to invite an experienced quality assurance professional to join their team in Hong Kong. about the team.There are over 200 employees at the company across Hong Kong and China. Currently they have just set up a new office in Europe. For this position, the candidate is expected to oversee and manage the QA, QE and RA teams in Hong Kong and Mainland China, with over 30 staff under this position. about the job.As a Senior Quality Assurance Manager (Head of Department), you are responsible for- Manage and develop the QA, QE and RA team in Hong Kong and China.- Maintain and improve company quality system in full compliance with ISO 13485 and FDA QSR.- Motivate and monitor the performance of the quality team.- Initiate and lead quality assurance activities, including audits, client feedback/ compliants, supplier management, NCMRs, CAPAs, product release and document review/ control.- Supplier evaluation and audit to ensure product quality is up to company standard.- Lead the setup of the new office in Europe and ensure all qualification would be acquired. skills & experiences required.To be successful at this position, you need- At least 10 year QA, RA and QE experience within medical device industry, with at least 5 year people management experience.- Strong knowledge in ISO13485, FDA QSR, and other ISO regulatory requirements and guidelines is a must.- Education background in engineering, life science or related disciplines.- Experience in handling plastic medical products such as valves and tubing is a big plus.

skills

no additional skills required

qualification

no additional qualifications required

educational requirements

Bachelor Degree