Quality Systems Specialist II
 Lodi, CA


  • Review records and documents, for completeness and compliance with QSR and ISO requirements.
  • Review batch record to support release of raw materials, work in progress products.
  • Generate standard operating procedures to define and improve quality system functions.
  • Support the Material Review Board, for the assessment and disposition of non-conforming materials and closure of Non-conformance and Deviation Reports.
  • Support the eDMS electronic documentation process as needed.
  • Lead and participate in interdepartmental initiatives for continuous improvement.
  • Provide companywide training on general quality principles and specific procedural requirements.
  • Facilitate process improvement within other department, through the use of training, coaching, and team participation.
  • Support the corrective action program, with hands on ownership for investigation and resolution of issues.
  • Participate in the internal auditor program.
  • Support QS Manager to implement and monitor Manufacturing and Quality Systems procedure
  • Education and Experience (in years):
  • High school degree (or equivalent experience) with 5 years of relevant work experience


  • Excellent verbal and written communication skills in group or one-on-one settings.
  • Computer skills, e.g., word, excel, access, Microsoft project, electronic documentation systems.
  • Ability to interface well with people of varied backgrounds, and to guide groups toward effective dynamics.
  • Understanding of general mathematical principles and calculations, at college entry level.
  • Experience in compiling data to support metrics analyzing current process.
  • Understanding root cause analysis, failure analysis, six sigma and general troubleshooting principles, and the ability to transfer those skills to others, either individually or in a group setting.
  • Detailed and quality oriented.
  • Strong organizational skills.


  • Complete all assigned and required training satisfactorily and on time


  • Experience in DNA diagnostics or other medical devices
  • Certified Quality Auditor or similar certification. (ASQ)


  • Ability to work in an office environment
  • Maintain flexibility in work schedule as interface with personnel on 2nd and 3rd shifts are sometimes required.
  • Frequent walking between locations