Remote Senior QA Auditor – Global Regulatory Compliance

Medline International Two Australia Pty; 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

Medline International Two Australia Pty is seeking a Senior Auditor QA to conduct audits of a global supplier base against FDA regulations and ISO standards. The role includes leading complex supplier regulatory projects and conducting internal audits of Medline divisions.

Applicants should have at least 4 years of experience in FDA regulated industries and a Bachelor's degree in a relevant field. This remote role requires travel up to 50%. A competitive salary range of $92,000 - $138,000 is offered.

Qualifications

• At least 4 years of experience auditing FDA regulated medical devices or pharmaceuticals.
• Experience applying knowledge of process validation, method validation, and sterilization processes.
• Experience with FDA regulations (21 CFR 820, 21 CFR 210/211).

Responsibilities

• Audit a broad, global supplier base against FDA regulations and ISO standards.
• Lead complex supplier regulatory projects involving cross-functional teams.
• Conduct internal audits of Medline divisions and manufacturing sites.

Skills

Detail-oriented

Excellent oral and written communication skills

Ability to manage concurrent projects

Education

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

Job description

Medline International Two Australia Pty is seeking a Senior Auditor QA to conduct audits of a global supplier base against FDA regulations and ISO standards. The role includes leading complex supplier regulatory projects and conducting internal audits of Medline divisions.

Applicants should have at least 4 years of experience in FDA regulated industries and a Bachelor's degree in a relevant field. This remote role requires travel up to 50%. A competitive salary range of $92,000 - $138,000 is offered.