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Quality Manager - Medical Devices

First Alliances' client
Updated: 18/01/2019

Employment Information


  • Insurance
  • Travel opportunities
  • Allowances
  • Incentive bonus
  • Health checkup
  • Training & Development
  • Salary review
  • Annual Leave

Job Description

1. Manage Quality Assurance, Quality Systems, Quality Control, Regulatory Affairs, Supplier Quality, Calibration, Complaint Handling, and Document Control staff.
2. Train company employees on compliance with Quality System standards 21 CFR 820, ISO 13485 and ISO 14971.
3. Develop and implement Quality System management strategies which integrate
with company annual and long term strategies.
4. Ensure company is regulatory inspection ready at all times (FDA, international
regulatory bodies and customers)
5. Direct investigations and implement corrective actions to resolve complaints and non-compliance
6. Plan, coordinate and direct regulatory strategies for new products.
7. Participate with the Management Team in developing and implementing relevant business and strategic plans.

Job Requirement

1. BS/MS in Life Science or Engineering 
2. Certain years of experience Quality Systems/Regulatory Compliance submissions of Class I and Class II medical devices. 
3. Minimum 3 years of experience at the Senior Manager, Associate Director or Director level.
4. Extensive knowledge of CFDA Medical Device Regulation, ISO 13485, ISO 14971, FDA QSR and CE marking
5. Proven track record of building successful teams. 
6. Competence and confidence leading teams and developing a cohesive team atmosphere. 
7. Proficient in Excel, Word, and MS Office/PC applications. 
8. Excellent verbal and written communication skills in English Language.

More Information

  • Degree: Bachelor
  • Age: Unlimited
  • Job type : Permanent

Company Overview

First Alliances' client size: 100-499
Established in 1998, First Alliances is the most well-known as the leading HR consultancy in Viet Nam. We are proud to be the pioneer and constantly...Detail

Quality Manager - Medical Devices

First Alliances' client

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