Quality Engineer (QE, CQE, PQE)

Job Responsibilities:

Process Establishment, Maintenance and Control

• Setting agreed clear requirement with customer through quality plan
• Leading and coordinating FAI report

Ensures compliance of customer requirements, industry standard and safety at work place

• Primary interface with customers on quality related matter
• Lead activities to improve yield at customer incoming and reduce RMAs
• Lead, participate and support regulatory and customer audits at site

Drive Proactive Continuous Improvement on Yield & Quality Metrics

• Ensure effectiveness of pFMEA
• Work with suppliers on incoming material's quality
• Conduct audit
• Driving the cross-functional team to deliver continual improvement activities for internal processes deliverables

Build and Embed Quality Awareness in Operations

• Ensure effectiveness of training and inspections
• Educate operators and production associations on quality/compliance and procedure

Provide Supervision to QA Supervisors/Inspectors/Technicians

• Supervise QA operators/group leaders/technicians in ongoing quality improvement activities

Provide Technical Guidance & Communications to Engineers/Technicians

• Lead or guide engineers to respond effectively to customers' feedbacks/CAPA, follow up with quality metrics set in quality plan
• Prepare Quality Operations Review
• May perform other duties and responsibilities as assigned.

Job Requirements:

• 2-3 years working experience in manufacturing quality assurance in Medical industry.
• Familiar with ISO9001, ISO14001, ISO45001, ISO13485, IATF16949
• Experience in quality analysis, problem solving, and project management and customer audit
• Experience in SPC, FMEA, PPAP, APQP, Control Plan, IQ, OQ, PQ, and MSA
• Familiar with CNC-Turning and Milling, Cold Heading, Stamping, Screw and Die-Cut process
• Working independently and with minimum supervisions
• Show strong leadership and self-driven motivation to achieve excellent result
• Able to speak, read and write Chinese due to customer and counterpart from China