Quality Engineer III - Quality Assurance in Pleasanton, CA at Apex Life Sciences

Date Posted: 6/4/2018

Job Snapshot

Job Description


Responsibilities:

  • Identifies and implements effective quality control systems to support the research and development of a clinical lab.
  • Leading the clinical lab validation activities of all the equipment.
  • Quality lead in driving implementation of required documentation and controls for new clinical development lab.
  • Revise and create SOPs.
  • Establishing lab equipment calibration and preventative maintenance needs.
  • Leading quality activities to assure the lab is compliant to internal and external standards.
  • Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Implement lab controls by developing and facilitating use of standardized procedures
  • Ensure that developed procedures and specifications are appropriate and followed.
  • Archive, store and maintain all document files to comply with Corporate and Site policies in a state of audit readiness.
  • Work cross departmentally to address quality issues.
  • Monitor and report on project needs and respond in a timely manner for problems.
  • Perform other duties as may be required or necessary.



Minimum Qualifications:

  • B.S. degree in Engineering, Technical or related field
  • 5-10 years of experience in a Quality role.
  • Experience with Quality tools/methodologies.
  • Detailed knowledge of FDA, GMP/GLP, ISO 13485, and ISO 14971.
  • Solid communication and interpersonal skills.
  • Project management and leadership skills, including the demonstrated ability to resolve quality-related issues in a timely and effective manner.
  • Advanced computer skills, including statistical/data analysis, SAP, Oracle E1, TrackWise, and report writing skills is preferred.
  • Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing).
  • Good organization and multi-tasking skills and drive for results and making sound business decisions.
  • Strong knowledge of using Microsoft Excel and Word required