Contract position: An American multinational biotechnology product development company who is a leader in genetic testing and precision laboratory equipment markets is currently seeking a Quality Engineer in the Pleasanton, CA area. This is a 6-month CONTRACT position. No per diem available.
Responsibilities for the Quality Engineer
Requirements for the Quality Engineer
- Identify and implement effective quality control systems to support the research and development of a clinical lab.
- Lead the clinical lab validation activities of all the equipment. Quality lead in driving implementation of required documentation and controls for new clinical development lab.
- Establishing lab equipment calibration and preventative maintenance needs. Leading quality activities to assure the lab is compliant to internal and external standards.
- Bachelor's degree in Engineering, Technical, or related field. At least 5 years of experience in a Quality role. Experience with Quality tools/methodologies.
- Detailed knowledge of FDA, GMP/GLP, ISO 13485, and ISO 14971. Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing).