Senior Engineer, Product Quality

Suzhou, Jiangsu
Permanent
Full-time

21 days ago

Work Flexibility: OnsiteKEY RESPONSIBILITIES / DUTIES主要职责:Responsible for developing, applying, revising, and maintaining quality standards/procedures to support manufacturing activities. Making sure the GMP and ISO13485 requirements are implemented correctly and followed strictly.

Review NC report to check its compliance to procedure requirements, and ensure proper NC/CAPA process is followed strictly
Maintain NC/CAPA log system to ensure its accuracy
Support CAPA Leader to manage CAPA metrics and prepare weekly/monthly report
Support CAPA Leader to deliver the required NC/CAPA training, and improve CAPA process
DCC related work independently (maintain document master list, record archiving, distribution & retrieval)
CM related work independently (ECR scan & registration, Coordinate Basic Windchill training & testing)
Other task assigned by supervisor

SUPERVISORY RESPONSIBILITIES管理职责:

None

REQUIRED SKILL SET岗位技能：

Excellent logical thinking
Effective interpersonal and trouble-shooting skills
Good communication skills and training skills.
Basic PC skills & good operation skills of Excel
Quick learner

RELEVANT EXPERIENCE经验要求：

More than 5 years in Quality Assurance or related functional area preferred
Experience in GMP or ISO quality systems

EDUCATION教育背景：

College / B.S. in engineering or engineering related discipline.

Travel Percentage: None

Stryker

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