6587 - Project Administration Engineer

Project Administration Engineer Responsibilities:

• 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.
• Conduct PM activities in the Life Science Industry ensuring the project meets the demands of the client.
• Understand Lifecycle management for Quality Applications.

Requirements:

• Must be willing to work onsite in Indianapolis, IN.
• Associate's degree in Engineering, Life Sciences, or a related field.
• 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
• Strong interpersonal skills and extremely resourceful

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