Auditor QA (Medical Devices)

Location: Remote, but must be located in the Chicagoland area, Illinois; travel up to 50% domestically and internationally is required.

Salary: $79,000–$119,000 annual, plus bonus and/or incentive eligibility.

Company

hirify.global is a global medical products organization offering quality, regulatory, and manufacturing solutions across a broad healthcare product portfolio.

What you will do

• Plan, schedule, and execute complex audits of global suppliers, contract sterilizers, laboratories, hirify.global divisions, and manufacturing sites.
• Evaluate quality management systems and compliance with FDA regulations, ISO 13485, MDSAP, MDD/MDR, and other global regulatory requirements.
• Assess compliance risks across systems, facilities, processes, and procedures, including novel products and services.
• Evaluate supplier approval status and support the development of regulatory and quality management systems for potential suppliers.
• Manage quality initiatives, improve internal processes, and create or revise procedures and SOPs.
• Prepare audit reports, follow up on CAPA actions, communicate findings to upper management, and support FDA inspections and regulatory responses.

Requirements

• Bachelor’s degree in microbiology, chemistry, engineering, or a related field.
• At least 2 years of experience auditing FDA-regulated medical device or pharmaceutical manufacturing or testing, or at least 3 years in a quality role within medical device or pharmaceutical manufacturing.
• Strong oral and written communication, attention to detail, judgment, and ability to draw clear conclusions from complex information.
• Ability to manage concurrent projects, competing priorities, and critical deadlines with limited supervision.
• Must be located in the Chicagoland area and able to travel up to 50% for business purposes.

Nice to have

• Experience with FDA regulations, including 21 CFR 820 and 21 CFR 210/211.
• Experience with ISO 13485, process validation, method validation, and sterilization processes.
• Experience managing CAPA programs.

Culture & Benefits

• Competitive total rewards package with continuing education and training opportunities.
• Health insurance, life and disability coverage, 401(k) contributions, and paid time off for eligible employees.
• Employee assistance, employee resource groups, and employee service opportunities.
• Commitment to an inclusive workplace and career development.