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System One Services QA Lead in Waltham, Massachusetts

QA LeadWaltham, MA



Category:Scientific & Clinical

Job ID:155392

Date Posted:09/02/2020

QA Lead


  • BS in Biological Science or related field

Required Skills & Experience:

  • 5-7 years experience in Quality Assurance in an ISO 9001 certified Quality Management System or equivalent

  • Experience leading/supervising team members

  • Experience and knowledge of IT software platforms that supportQuality Management Systems

  • Experience with deviation investigations, root cause analysis, Out of Specifications and review/approval of complaints

  • Understanding ofGood Documentation Practices

Position Summary:

  • Leads the Quality Associates in the identification, review and approval of complaints, deviation investigations and Out of Specifications (OOS) results, root cause analysis and generate corrective actions to improve processes/systems

  • Responsible for the management of Quality Associates in support of product release

  • Will manage, mentor and motivate their direct report

  • Will work closely with the manufacturing team assisting withQuality Management Systemssuch as non-conforming materials, deviations and corrective actions

  • Final approval of quality investigations. Assist with the Product/Process Change Control process and Ability to identify, detect and escalate quality related trends

Location:Waltham, MA

Duration:Direct Hire