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Project Engineer

Project Engineer

LS SolutionsIndianapolis, IN, United States
30+ days ago
Job type
  • Full-time
Job description

Project Engineer

Indianapolis,IN

This job is to support handling customer complaints. Objectives include

Support timely completion of product complaint investigations, in compliance with global and local procedures

Assess incoming complaints and determine next steps needed to adequately address the complaint issue(s) in a timely manner

Determine the appropriate level of return sample analysis needed

Perform visual and / or functional analysis as needed

Verify and close relevant complaints with minimal supervision

  • Support inventory management of complaint samples
  • Support QA personnel in writing GMP documents, and completing complaint process metrics, including second person verification (SPV) of complaints data

Minimum requirements

Strong computer literacy in all Microsoft Office applications

  • Strong attention to detail
  • High degrees of self-management and problem solving

    • Ability to work under tight deadlines

    Additional preferences :

  • Knowledge of regulatory requirements (e. g. cGMP, 21 CFR 820, ISO 13485, Canadian MDR)
  • Knowledge of complaint handling and quality systems; device / combination product complaint experience preferred
  • Veeva QualityDocs experience
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