Job Description

Quality assurance for new project quality development.

Position Location
QDG Dongguan
Responsibilities
Set the quality assurance and regulatory compliance request for new project transfer, review and revise the related quality agreement and compliance certification and registration request.
Take part in new process development for new products, identify the risks from the new process, and define proper activities to control the risks.
Participate in creating the VMP (Validation Master Plan), and review OQ (Operation Qualification) and PQ (Performance Qualification) to ensure all risks are validated effectively.
Align cosmetic criteria with customers.
Establish specific test methods for products and implement TMV (Test Method Validation).
Establish control procedures for new products to meet sterilization requirements.
Create process control plans and related work instructions for inspection.
Align material acceptance criteria and establish work instructions for incoming materials.
Align test/inspection methods with vendors, such as tooling selection, TMV protocol, etc.
Verify if incoming materials meet the requirements for prototype sample building.
Requirements
Bachelor’s degree in Engineering or Science.
More than 5 years of quality assurance work experience.
Familiar with new product development procedures and basic quality tools.
Proficient in English communication.
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