Quality Systems Analyst


Fremont, CA

What you'll be doing

Responsible for evaluating, developing and implementing quality system feedback process to achieve goal in accordance with established QSR, ISO, CMDR and IVDD regulation. Provide support to operation in gathering and analyzing process control data using quality tool. Under general supervision, analyze trend report and recommend corrective action where necessary. Analyze situation or data, exercising sound judgment within defined procedure and practice to determine appropriate action. Participate on project team as a contributing member and assist with internal audit as required. Develop and implement quality system procedure as directed.

What your background should be

Minimum three to seven years of experience within the medical device industry including CAPA handling, internal and external auditing and project management experience. Prior IVD experience preferred. Must have excellent written and oral communication skill, and a strong track record of working cross functionally. Must have demonstrated ability to think strategically. Must have demonstrated ability to manage multiple activity and task. Must have demonstrated use of quality tool methodology and strong computer skill.

Required Schooling / Training

Bachelor degree

Who is the client company

A multinational biotechnology product development company that providing analytical and laboratory products and services.
If you are interested in this position, send your resume to apply@kochdavis.com