Quality Engineer/Scientist

Location
95054, Santa Clara. San Jose, Bay Areas. We consider local applicants only.
Salary
Competitive salary with 100% covered medical, vision and dental coverage.
Posted
May 02, 2018
Ref
MBI0518002
Required Education
Bachelors Degree
Position Type
Full time

This positions reports to the QA/QC Manger and shall be responsible to shared duties between the Quality and Operations systems. Responsible to maintain company-wide Quality Systems (QMS) Must have a thorough understanding of the Quality Policies of the company and ensure the other departments are in compliance with our procedures. Must have experience with NC/CAPA systems and the Design Control process. The position will provide Quality and Regulatory support to the manufacturing and R&D activities within the company.

Requirements

  • B.S degree, M.S degree preferred .
  • Experience with the execution of quality systems like CAPA, NCMR, deviations and document control
  • Experience with Medical Device inspection and testing
  • Knowledge of Quality Systems regulations including 21 CFR 820 and ISO 13485
  • Excellent skills in organization, record keeping and communications
  • High level of experience and understanding of GMP/GLP system requirements
  • Excellent oral and written communication skills
  • Collaborative and proactive attitude a must
  • Able to adapt to a fast-paced work environment and must have a strong work ethic to complete assignment with high quality under tight deadlines

Responsibilities:

  • Work with QA/QC manager to execute and maintain the NC/CAPA system
  • Perform verification testing on manufacturing materials
  • Provide Quality support to the QMS activities within the company specifically the Design Control process
  • Working on multiple, simultaneous projects, which require you to be able to manage time flexibly and interact with a variety of people