PQA Engineer--某美资医疗设备工厂

 

Responsibilities:

 

1.   Develop, release and maintain Quality plan, IQC plan and FGA procedureon any project.

 

2.   Handle customer complaints (Out of box quality issues). Leadinvestigation and improvement of out of box quality issues for specificproducts with cross-functional teams.

 

3.   Keep tracking of product quality performance for both in-line andcustomer quality (OOBQ,FPY, DPU, COPQ, IPQC). Co-ordinate Root Cause Analysisand, when applicable, CAPA to improve quality for both product and process.

 

4.   For new projects, PQA engineer is to do the followings:

 

1)   Develop &implement Quality plan, process certification plan; Prepareprocess certification report; Determine equipment, tools and resources neededfor FGA; Track new product quality performance before mass production.

 

5.   Support regulatory function to keep Regulatory and Safety compliance.Support internal and external audits, participate in HSE, Lean manufacturingactivities.

 

6.   Review production and inspection records and approve products release.

 

 

 

Qualifications:

 

1.   Education, Professional experience:

 

    Bachelor degree with engineering background

 

2.   Technical knowledge:

 

    Over 5years working experience of QAposition

 

    Working experience as Project QualityEngineer is preferred

 

    Quality Management System knowledge is plus

 

    Familiar with quality control methodologyand tools . Six Sigma knowledge is preferred

 

3.   Personal characteristics:

 

    Good communication skills and facilitationskills

 

    Strong team work spirit

 

4.   Languages:

 

    English: Fluent spoken and written

 

    Mandarin: Fluent spoken and written

 

5.   PC-Knowledge:

 

    Fluent Windows / MS Word / MS Excel/Powerpoint