Overview
Quality Engineer Jobs in Milpitas, CA at Indotronix Avani Group
Title: Quality Engineer
Company: Indotronix Avani Group
Location: Milpitas, CA
Position: Quality Engineer
Location: Milpitas, CA 95035 (Locals only)
Duration: 06+ months
The pay rate is applicable only under W2 guidelines, and we do not offer sponsorships or transfers.
Responsible for reviewing and assessing Quality Notifications, Complaints, Deviation/Waivers and other cGMP activities for the assigned product lines in the instrument plant. Oversee operations and assure documentation and procedures are followed, updated and maintained as required by internal Quality Policies and related FDA/GMP guidelines. Conducts complaint investigations, assists in the investigation of manufacturing issues and provides data and input on technical issues and projects.
Education and Experience:
B.S. or B.A. degree in an engineering or science field.
Typically requires at least 3 years of experience in Quality / Supplier Quality in a manufacturing environment working in an FDA or ISO regulated environment
Six Sigma Green Belt and/or Certified (e.g. ASQ) Quality Engineer or equivalent (Prefer Six Sigma Black Belt Certified) desired
Minimum Qualifications:
Robust understanding of QSR, Design Control, ISO, Product Risk Management and GMPs as defined in CFR 820
Experience in managing variety of commodities including Instrument Finished Goods CMs, PCBAs/ Electronics, Sheet metal, Machined Parts, Optics/Lasers, and Cabling harnesses or Chemistry or Biological products.
Demonstrate knowledge of Statistics and Data Analysis to drive data based results and decisions
ISO 9001/13485 lead auditing experience
Experience in SAP, Minitab, and Quality Systems Software (e.g. Trackwise) is a plus
Lead Supplier Capability Assessments
