Senior Quality Engineer

Product Quality

·    Maintains quality engineering programs, standards and improvements within the organization.

·    Develops and initiates standards and methods for inspection, testing and evaluation based on medical device standards

·    Devise sampling procedures and designs and develops forms and instructions for recording, evaluating and reporting quality and reliability data.

·    Develops and implements methods and procedures for disposition of discrepant materials.

·    Directs inspection team engaged in measuring, inspecting and/or testing products or parts and tabulating data concerning materials, product or process quality and reliability.

·    Executes the inspection / testing of new equipment capability

·    Supervises inspection team on the inspection plan

·    Supports Product Engineering and Program Manager with customer interfaces as necessary on quality related issues.

·    Provides liaison to various regulatory bodies

·    Responsible for authorizing the released of final products to customer

·    Contributes to the workplace safety and health improvement for the employees, as well as environmental protection, by adhering to the company’s Environmental, Health and Safety policies and procedures, and helping to achieve EHS objectives and targets through participation of EHS programs

·    Participate and adhere to Corporate Social and Environmental Responsibility (CSER) policy, programs and procedures.

·    Assist others within same or cross-functional department assign by Head of Department/Manager on ad-hoc duties as necessary.

Job Requirements

• Typically requires a Bachelor Degree or equivalent experience
• Minimum 2 years of experience in similar capacity
• Familiar with ISO 13485 Quality System Requirements and FDA CFR Part 820 regulations
• Familiar with inspection equipment, statistical tools, Geometric Dimension and Tolerance knowledge will be an advantage
• Candidates with relevant experiences will be considered for Senior position