Senior QA Auditor, Sterilization and Global Compliance

Medline; Illinois; On-site; USD 92,000 - 138,000; Full time

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Job summary

A leading medical equipment manufacturer is seeking a Sr Auditor QA to ensure regulatory compliance and oversee complex audits across various product categories. This role requires a Bachelor’s degree in microbiology or related fields, along with extensive experience in FDA regulations and quality systems. The position offers an annual salary range of $92,000 to $138,000 and provides opportunities for further career development within a global organization.

Qualifications

• 4+ years auditing FDA regulated medical devices or pharmaceutical industries.
• Expert knowledge of FDA regulations (21 CFR 820, 210/211).
• Familiarity with ISO 13485 standards.

Responsibilities

• Lead complex supplier audits to ensure regulatory compliance.
• Conduct internal audits and CAPA follow-ups.
• Write audit reports and communicate results.

Skills

Attention to detail

Excellent communication skills

Project management

Education

Bachelor’s degree in microbiology, chemistry, engineering or related field

Job description

A leading medical equipment manufacturer is seeking a Sr Auditor QA to ensure regulatory compliance and oversee complex audits across various product categories. This role requires a Bachelor’s degree in microbiology or related fields, along with extensive experience in FDA regulations and quality systems. The position offers an annual salary range of $92,000 to $138,000 and provides opportunities for further career development within a global organization.