Quality Engineer - Onsite (Urgent Need)

Position

Quality Engineer

Location

San Jose, CA

Description

- 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

- BS or BA in related field required with 2 years of experience, or MS with no experience required (project management experience preferred).

Experience Needed

- Must demonstrate a working understanding of the pertinent Quality Systems Regulations (i.e.: Good Manufacturing Practices, ISO, FDA).

Education and Experience

- B.S. or B.A. degree in an engineering or science field.

Minimum Qualifications

- Robust understanding of QSR, Design Control, ISO, Product Risk Management and GMPs as defined in CFR 820

Skills

- Excellent people interaction, team building, leadership, and communication skills including providing effective presentations.
- Strong background in Manufacturing processes including process development and optimization
- 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
- Proficient in project management, analytical, critical thinking, problem solving and prioritization skills
- Demonstrate innovative and implementation skills
- Demonstrate knowledge of Statistics and Data Analysis to drive data based results and decisions
- ISO 9001/13485 lead auditing experience
- Strong Troubleshooting skills at both process and product level

Benefits

- Professional certification is an advantage (i.e. CQA, CQE, SQE, CQM, Six Sigma, etc.)

Pay

Not specified

Schedule

1st Shift