Manager Quality Assurance, Audit Sterilization/Micro
$116,000–$174,000 year
On-site · Northfield, Illinois, United States
Job Summary
Responsible for managing quality and regulatory compliance for assigned department(s); ensures adherence to applicable regulations (QSR, GMP, ISO) across product lifecycles and distribution regions; leads internal and supplier audits to meet FDA/ISO requirements for medical devices, drugs, and related products; manages CAPA/SCAR documentation and cross-functional regulatory projects; mentors auditors, conducts trainings, and drives continuous improvement; requires substantial travel (up to 50%), relocation may be available, and position is based near the corporate HQ in Northfield, IL.
Required Qualifications
- Bachelor’s degree in Engineering, Science, or Technical Field
- Minimum 5 years in senior level quality role within medical device or pharmaceutical manufacturing
- Experience with FDA regulations (21 CFR 820, 21 CFR 210/211)
- Experience with ISO 13485
- Knowledge of QSR/GMP/ISO requirements or similar regulatory frameworks
- Ability to travel up to 50% of the time
- Strong leadership and mentoring skills in audit teams
- Experience leading internal and supplier audits and CAPA/SCAR processes
- Proficiency in data analysis and regulatory reporting
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