Demo

Compliance Auditor III

Intellectt Inc
Forest, IL Full Time
POSTED ON 4/5/2025
AVAILABLE BEFORE 5/3/2025

Role : Compliance Auditor III

Location : Lake Forest, IL / 100% Onsite role

Duration : 06 Months

We are seeking a qualified individual with a technical background to join our team as a Quality Systems Auditor. The ideal candidate must be familiar with both US and foreign regulations, industry standards, corporate, and divisional policies. The individual will need to possess a solid understanding of Quality Systems Regulations (QSR) and International Standards (ISO 13485). A strong grasp of various quality and operational systems supporting facility operations, product design, development, production, distribution, and installation is essential.

Key Responsibilities :

  • Audit pricing contracts within the Model N system, ensuring compliance with contract documents and revenue management software.
  • Evaluate and verify quality systems, ensuring compliance with industry standards (QSR, ISO 13485).
  • Support the audit process for pharmaceutical and medical device manufacturing and R&D environments.
  • Provide insights into quality management principles, offering recommendations for continuous improvement.

Qualifications :

  • Bachelor’s degree in Engineering (preferred) or equivalent experience in the pharmaceutical or medical device industries.
  • Minimum of 4 years of relevant experience as an Internal Auditor, Quality Engineer, or Manufacturing Engineer in R&D or manufacturing settings.
  • Previous audit experience (minimum 2 years), with exposure to Model N or Revenue Management Software.
  • Excellent written and verbal communication skills, with the ability to effectively present findings and reports.
  • Key Skills :

  • Strong analytical skills and attention to detail.
  • Knowledgeable in contract compliance and audit processes.
  • Expertise in QSR and ISO 13485.
  • Proficiency in Model N or similar revenue management software.
  • Preferred Experience :

  • Familiarity with contract compliance audits and related systems.
  • Education :

  • Bachelor’s degree or equivalent experience in a relevant field.
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