Engr , Quality

Quality Engineer

Duration: 05 Months

Location:

San Jose, CA 95131

• Responsible to perform complaint investigation including reviewing and assessing Quality Notifications, DHR and Risk document 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.

• Minimum BS or BA in related field required with 2 years of experience.
• Typical degree in Mechanical or Electrical or Industrial Engineering, Biological Sciences, Chemistry, and/or Computer Science or other related field.
• Must demonstrate a working understanding of the pertinent Quality Systems Regulations (i.e.: Good Manufacturing Practices, ISO, FDA).
• Proven ability to develop solutions to a variety of problems of moderate scope and complexity, using policies and procedures for guidance.
• Capable of using Microsoft programs and ability to learn other systems.
• Effective verbal and written communication skills.
• The ability to work in teams and independently with minimal supervision to obtain results as required.
• Must be self-motivated/directed, organized, detail oriented.
• Professional certification is an advantage (i.e. CQA, CQE, SQE, CQM, Six Sigma, etc.).