Sr Auditor QA (Medical Devices/Pharmaceuticals)

Location: Remote, Illinois; travel up to 50% within the state, nationally, and internationally.

Annual salary: $92,000–$138,000, plus bonus and/or incentive eligibility.

Company

hirify.global is a growing worldwide organization supplying and manufacturing medical and healthcare products.

What you will do

• Plan, schedule, and execute complex, high-risk supplier audits covering FDA, ISO, MDSAP, MDD/MDR, and other global regulatory requirements.
• Conduct internal audits of hirify.global divisions and manufacturing sites, assess compliance risks, and follow up on CAPAs.
• Lead supplier regulatory projects and support Supplier Quality goals as a senior team leader and subject matter expert.
• Evaluate suppliers for approval and assist with quality management system development, acquisition due diligence, and integration.
• Write audit reports, communicate findings to senior management, and support responses to FDA and other regulatory observations.
• Mentor junior auditors and QA personnel while contributing to quality initiatives, procedures, and SOP improvements.

Requirements

• Bachelor’s degree in microbiology, chemistry, engineering, or a related field.
• At least 4 years auditing FDA-regulated medical devices or pharmaceuticals, or at least 5 years in a senior quality role within medical device or pharmaceutical manufacturing.
• Experience with FDA regulations, including 21 CFR 820 and 21 CFR 210/211.
• Experience with ISO 13485, process and method validation, and sterilization processes.
• Strong written and oral communication, prioritization, independent problem-solving, and concurrent project coordination skills.
• Ability to travel up to 50% for domestic and international business audits.

Nice to have

• Experience with USP 61/62 microbial testing of non-steriles.
• Experience managing CAPA and applying validation and sterilization expertise.

Culture & Benefits

• Competitive total rewards package with continuing education and training.
• Health, life, and disability insurance for eligible employees.
• 401(k) contributions and paid time off.
• Employee Assistance Program, Employee Resource Groups, and Employee Service Corp access for eligible part-time employees.
• Focus on inclusion, diversity, belonging, and career growth.