Sr Engineer , Quality Assurance

Leica Microsystems

Leica Microsystems

Quality Assurance
Pudong, Shanghai, China
Posted on Wednesday, September 18, 2024

Purpose/Objective:

To lead and /or drive the production quality improvement to archive the quality target, provide necessary professional support in quality field, help to build up robust process in order to deliver qualified products to the customers.

Area of Responsibilities:

Quality Management

Drive for internal continuous quality improvement and help company to achieve the defined quality target.

Coordinate with related functional teams for company wide quality improvement action plan.

Participate in customer complaint handling together with industry engineers, R&D, and provide report such as 8D, CAPA in time to customer.

To do the data analysis and find the opportunity to drive production for continuous corrective actions and preventive action.

To lead the weekly quality meeting with process engineers to review and monitor all of critical quality issue.

Provide necessary professional support to production on quality field to ensure the production can delivery qualified product to customer, final release authorization for the product in the process.

Handle and orginize the nonconformities review with the review board to ensure all of nonconformities been settled down in time and be well recorded. Participate in production process audit to reduce the potential risk of quality. Implement all of quality improvement action and ensure following the QMS procesures.

Participate in quality control for design transfer of NPI including DMR review, Process audit, PAP review, Process validation review, Pfmea review, ect.

Lead DBS Kaizen about quality project and be able to become supervisor of backup on the team

Person Specification

Bachelor degree majoring in Engineering ≥5 years of experience in manufacturing, knowledge in mechanical industry ≥3 years of experience in quality assurance related Experience of ISO13485, SFDA regulations are preferred Good team work spirit and communication skills

Good English and MS office skill, familiarity with SAP and OutLook preferred.

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