About the Role:
This individual will work as part of Quality team to support the Engineering Quality in the manufacturing site including R&D, new production introduction/NPI, mass production, local supplier quality management, as well as post marketing surveillance/PMS.
Key Responsibilities:
- Set up quality metrics and track quality data in order to maintain, improve product and process quality, lead local Quality management review in timely manner and drive for continuous corrective and improvement actions, collaborate with counterparts and cross-functional teams at headquarter.
- Work with cross-functionally with Product Development, Lifecycle management, Purchasing, NPI, Supply Chain teams to support new product launch. Provide quality support in the areas of design transfer activities by leveraging appropriate quality engineering resource.
- Oversee engineering quality functions including Supplier Quality Management and Product Quality Management. Provide technical support and training to quality team members, ensure quality performance and awareness. Ensure consistency, reliability and compliance with GMP, QMS and ISO13485, FDA CFR 820 requirements.
- Support and drive Malaysia MFG site quality activities including SCAR, NC and CAPA review, Provide Quality input and approve for Product and Process Change, Review and Approve validation(3Q) protocols, reports and product control related documentation.
- Responsible for incoming inspection, in process inspection until product release, lead PMS activities including product customer complaint, failure analysis.
What We're Looking For (Qualifications):
- Full-time bachelor's degree or above in EE/ME/Engineering
- 5+ years of relevant experience of quality assurance/quality engineer experience in mature mass manufacturing environment, prefer MNC working experience.
- Rich experience of in DQE, supplier management, process quality engineering, NC and CAPA.
- Good understanding of GMP, ISO13485 or FDA QSR820
- Logic thinking, good communication skill, flue mandarin and basic Chinese reading
- Travelling less than 25%
We Offer A Competitive Package And The Opportunity To Make A Real Impact. If You Are Ready To Take On This Challenging And Rewarding Role, We Encourage You To Apply!
