1.Job responsibilities
a. Responsible for establishing the V&V master plan for all the company's manufacturing equipments.
b.Writing V&V protocols according to the company's SOP.
c.Take lead to pererrorform the V&V for the company's new equipment and existing equipments on a regular basis.
d.Assist with the equipment outsourcing team making sure the sourced equipment is acceptable.
e.Other jobs associated with the V&V .
2.Key qualifications
a.B.S. or above major in engineering or science.
b.3+ years' working experience in process& equipment V&V as a team leader. In particular the experience in medical device field is preferred.
c.Be familiar with ISO 13485 and GMP. Especially the application experience in process control is a must.
d.Good application skills with six sigma, especially in statistical analysis such as SPC, MSA, etc. Capable of using the data analysis tools like Excel, MINITAB software.
e.Good English skills in both written and speaking English.
f.Do not have infectivity, hereditary disease or spiritual, etc.