Quality Associate II (Audit)
Baxter · Round Lake, IL
QualityFull-time$88k–$121kCompany career page
The apply link worked recently (not employer-confirmed).
Role summary
Quality Associate II leading compliance audit processes and internal/external audit activities at a medical device manufacturer. Manages corrective actions, regulatory intelligence, and inspection readiness while mentoring junior team members on audit methodology and compliance standards.
What they're looking for
- Bachelor's degree in business, science, or equivalent
- Minimum 3 years quality experience in medical device, pharma, or regulated industry
- Minimum 3 years cGMP internal or external auditing experience
- ASQ CQA or equivalent auditor accreditation strongly preferred
- Extensive knowledge of quality and regulatory standards
- Proficiency in quality software systems and MS Office
- Strong analytical, communication, and project management skills
What you'll be doing
- Manage tracking, reporting, and closeout of corrective and preventive actions from audits
- Conduct internal and supplier audits with objective evidence collection and risk analysis
- Lead regulatory intelligence activities including FDA guidance and warning letter distribution
- Support external regulatory inspections and manage compliance documentation
- Prepare management reports on compliance trends and metrics analysis
Privacy & handoff
This role links to Baxter's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.