Responsibilities:

• Responsible to work across a variety of functional groups that are directly involved in engineering, product development, implementation, and contract manufacturing partners.

• Responsible to monitor supplier’s performance in area of Production Capacity, Productivity, Quality, and New Product Introduction.

• Evaluates electrical systems, products, components, and applications by designing and conducting research programs; applying knowledge of electricity and materials.

• Confirms system's and components' capabilities by designing testing methods; testing properties.

• Develops electrical products by studying customer requirements; researching and testing manufacturing and assembly methods and materials.

• Ensure process / component changes as requested by suppliers have the appropriate level of technical assessment, control, and approval.

• Assures product quality by designing electrical testing methods; testing finished products and system capabilities.

• 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/Engineering 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.

• Oversee the performance of the product/process qualification process of the manufacture devices while reviewing investigations from the Contract Manufacturer.

• Work with the Contract Manufacturer to ensure the health of their quality systems – focusing on Contract Manufacturer CAPA, SCAR, nonconformance closure and Supplier Performance.

• Perform verification checks on Third Party customer product to ensure any new or amended requirements on checklist are updated at Contract Manufacturer site.

• Participate in First Article Approval plan or test plan for customer startup and lot shipment controls.

• 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.

• Conduct weekly compliance/quality review with contract manufacturer team.

• Coordinate requests from customer team to ensure timely information transfer to Contract Manufacturer.

• Driving industrialization and Quality/Engineering improvement projects.
  

Requirements:

• Degree holder Electrical & Electronic Engineering and Quality related, and at least 5 years of experience in the electronic/medical device industry, or an equivalent combination of education and experience.

• Strong understanding of electrical manufacturing processes.

• Quality related certificates (such as CQA, ASQ or equivalent is much preferred).

• Superior English skills are a “must have”.

• In addition, managing a cGMP factory Engineering/QA team and process is essential.

• Prior experience using some form of quality management software system is critical.
  

上班地址：沙井