深圳招聘

Job Description:

The Quality Engineer will have overall responsibility for assuring that the Contract Manufacturer’s Quality System Requirements and Consumer Electronic/Medical Device Product Evaluation activity are effectively established, implemented and maintained in compliance with industrial and other regulatory requirements.

Responsibilities:

• Responsible for leading efforts associated with ensuring the highest quality of the manufactured devices.
• Collaborate with departments to ensure validation and compliance activities are executed efficiently and effectively, and in accordance with all governing documents and external guideline.
• To plan and conduct continuous on-site audit ensure the documents in place are exactly implemented in facility.
• Coordinate supplier change information back to the customer Quality team while providing all the details for the evaluation.
• Review and approve non-conformances relating to disposition of non-conforming material while collaborating with customer team and Contract Manufacturer.
• Review validation activities associated with various aspects of the product and testing equipment that is used in the manufacturing process.
• Provides Technical support, compiling information from various sources to aid the identification and resolution of quality problems and initiatives.
• Work directly with supplier’s Production Engineering and Quality Engineering Departments closely to plan and execute supplier’s product, semi-assembly and component in a systematic way to capture the quality improvement progress status.
• To review and validate supplier test jig design and set up.
• To review and improve supplier’s quality performance in a systematic way, with product / process related quality performance from IQC, IPQC, Production scrap rate, QA, OQA findings and customer feedbacks.
• To capture the knowledge base for design practice, manufacturing process, test protocol, product quality evaluation framework for cross ferritization between products and manufacturing sites.
• Provides Technical support, compiling information from various sources to aid the identification and resolution of quality problems and initiatives.
• Review validation activities associated with various aspects of the product and testing equipment that is used in the manufacturing process.
• Work with the Contract Manufacturer to ensure the health of their quality systems – focusing on Contract Manufacturer CAPA, SCAR, nonconformance closure and Supplier Performance.
• To support merchandizing department on the product evaluation activity and follow up the Product Analysis Report (PAR) and reliability test plan with Contract Manufacturer.
• Participate in First Article Approval plan for customer start up and lot shipment controls.
• To conduct new product evaluation on Electronic Consumer Product/Medical Device.
• To develop/maintain the Constructional Data Form (CDF) for QC inspection.
• Perform verification checks on Third Party customer product to ensure any new or amended requirements on checklist are updated at Contract Manufacturer site.
• Perform verification checks on Quality Control Inspection report before release to customer.
• Publish necessary report to customer team on the status of production output, Lot qualification testing results and shipment schedule for Customer and resolve any issues.
• Perform periodical compliance/quality review with contract manufacturer team.
• Coordinate requests from customer team to ensure timely information transfer to Contract Manufacturer.
• Driving industrialization and Quality improvement projects.

Requirements:

• Degree holder in engineering related, and at least 3 years of experience in the mechanical or industrial engineering, or an equivalent combination of education and experience.
• Prior actual Medical Device Manufacturing, Quality Engineering, Reliability Engineering or Test Engineering experience with an industrial manufacturing firm experiences would be preferred.
• Good English and Mandarin skills is a “must have”.
• Robust understanding of CAPA and NC protocols, standard practices, and root cause analysis investigation techniques.
• Ability to work independently and cross-functionally in a dynamic environment.
• Work with suppliers based in southern part of China.
  

We are Hong Kong based company with operation in Shenzhen, Lo Wu, China.
We are providing supply chain service to oversea customers, from product sourcing, quality evaluation, production monitoring till shipment.