We are seeking an experienced and skilled Sr Quality Assurance Auditor to join our team, responsible for ensuring compliance with regulatory standards and internal quality requirements across our global supplier base and internal manufacturing sites. As a subject matter expert, you will lead complex projects, perform audits, and collaborate with cross-functional teams to drive quality excellence.
Key Responsibilities
- Conduct comprehensive audits of global suppliers and internal manufacturing sites to ensure compliance with FDA regulations, ISO standards, and other applicable global regulatory requirements, covering a wide range of products, including sterile products, APIs, raw materials, medical devices, pharmaceuticals, biologics, cosmetics, medical foods, and dietary supplements.
- Perform internal audits of Medline divisions and manufacturing sites to ensure adherence to quality standards and regulatory requirements.
- Lead critical supplier regulatory projects, collaborating with cross-functional teams to drive quality excellence and compliance.
Requirements and Qualifications
- Bachelor's degree in Microbiology, Chemistry, Engineering, or a related field.
- Minimum 4 years of experience auditing FDA-regulated medical devices or pharmaceuticals, or 5 years of experience in a senior-level quality role within medical device or pharmaceutical manufacturing.
- In-depth knowledge of FDA regulations (21 CFR 820, 21 CFR 210/211) and ISO 13485.
- Experience with process validation, method validation, and sterilization processes.
- Excellent oral and written communication skills, with the ability to listen, process, and prioritize complex information.
- Proven ability to work independently, manage multiple projects, and meet critical deadlines.
- Willingness to travel up to 50% of the time for business purposes (domestic and international).
Preferred Qualifications
- Experience with USP 61/62 for Microbial Testing of Non-Steriles.
- Experience in CAPA (Corrective and Preventive Actions) management.
What We Offer
- Competitive total rewards package.
- Ongoing education and training opportunities.
- Tremendous growth potential with a global organization.
- Comprehensive benefits package, including health insurance, life and disability, 401(k) contributions, paid time off, and more.