Job Listing Description

Quality Engineer

Description:
Job Description

Digital Science provides Information systems to regulated and non-regulated customers. The Quality Engineer will be responsible for working with Process Owners to create and improve QMS processes that meet the business requirements.



 



Responsibilities:



  • Work with Functional Process Owners Create workflows and textual processes in alignment with QMS requirements
  • Work with Processes Owners and QA to improve existing processes
  • Assist with other QA activities as needed (could include tool validation, CAPA management, Quality tool implementation)

Additional Info

  • This is a true Quality Assurance Engineering position.
  • Manager is looking for a Senior person, not Junior
  • Experience with Six Sigma, QMS, Business Improvement
  • Vizio, QMS, ISO 9001, Six Sigma
  • Ability to sit with a group of SME and map out the business process
  • Pharmaceutical / Life Sciences a major plus
  • GxP Regulation

Mandatory Skills/Knowledge



  • ISO 9001
  • GAMP 5
  • GxP requirements
  • 21 CFR Part 11
  • Experience of working in a software company
  • Good written and verbal communication skills


Preferred Skills/Knowledge



  • SOC 2 or ISO 27001
  • Xaas
  • AWS
  • Computer System Validation
  • Hipaa/GDPR

 
Job Number: 2010115657
Job Location:
Duration: 7 months
Input Date: 06/24/2020
Last Updated: 07/14/2020
Firm Name: PDS TECHNICAL SERVICES
Attention: Jack Beabout
Address: 2154 N CENTER ST STE 405D
City, State: NORTH CHARLESTON, SC 29406
800 Phone: 866/224-2745
Email: southeastjobs@pdstech.com
Website: https://pdsjobs.force.com/candidates/job_detail?id=a1i1T000003OvOdQAK&URLSource=cjhunter

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