Title: Quality Auditor
Duration: 6 months Contract + extension
Location: Remote (travel required)
Pay Range: $30-50 per hour
Mission:
Ensure supplier and vendor quality systems meet regulatory and company standards by conducting quality audits, documenting findings, and supporting compliance initiatives across domestic and international suppliers.
Day-to-Day:
We are looking for a Quality Auditor to assist with supplier and vendor audits for medical device and pharmaceutical manufacturers. This individual will partner with senior auditors to prepare for audits, review quality documentation, identify compliance gaps, and document audit findings. The role requires approximately 50–60% travel, primarily within the U.S., with occasional international travel to Canada or Europe. All travel expenses are covered by Medline, and travel logistics will be coordinated by the Hiring Manager and Travel Manager.
Must Haves:
- 2–10 years of Quality Assurance or Quality Auditing experience within the medical device or pharmaceutical industry
- Hands-on experience participating in or completing supplier/vendor audits
- Knowledge of FDA regulations, including 21 CFR Parts 210, 211, and/or 803, along with ISO 13485
- Experience working with Quality Management Systems (QMS), CAPA, and supplier quality processes
- Manufacturing floor or production quality experience with strong documentation and communication skills
- Valid passport and ability to travel 50–60%, including occasional international travel
Interested candidates can send their resume to aneesha.chowdhury@collabera.com or reach me directly at 312.724.7929
The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, and paid holidays annually – as applicable.