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.