Manager Quality Assurance, Audit (Medical Devices)

Location: Remote within commuting distance of the corporate headquarters in Northfield, Illinois; business travel required for up to 40–50% of the time, including domestic and international travel. Relocation assistance may be available.

Salary: $116,000–$174,000 annual, plus bonus and/or incentive eligibility.

Company

hirify.global is a growing worldwide organization providing products across medical device, pharmaceutical, biologics, cosmetics, medical food, and dietary supplement categories.

What you will do

• Lead internal and supplier audits across hirify.global divisions, manufacturing sites, laboratories, contract sterilizers, and a broad global supplier base.
• Ensure compliance with FDA, QSR, GMP, ISO, and other applicable global regulatory requirements across product life cycles and distribution regions.
• Manage complex supplier regulatory projects involving cross-functional teams, including CAPA and SCAR documentation.
• Oversee the internal audit team, maintain audit schedules and metrics, and mentor and train auditors on updated regulations.
• Review audit observations, participate in escalation meetings, and support product evaluations from quality assurance and regulatory compliance perspectives.
• Identify and manage continuous improvement projects while coordinating competing priorities and critical deadlines.

Requirements

• Bachelor’s degree in engineering, science, or a technical field.
• At least 4 years of experience with medical device or drug combination product platforms, design controls, risk management, and regulated-industry requirements.
• Knowledge of 21 CFR 820, 21 CFR 210/211, ISO 13485, ISO 14971, MDSAP, MDR, QSR, and GMP.
• Experience with process validation, method validation, and sterilization processes.
• Ability to analyze and report data, coordinate concurrent projects, manage deadlines, and work independently.
• Advanced Microsoft Excel skills, including pivot tables and data analysis.

Nice to have

• At least 4 years of supervisory or managerial experience in quality or regulatory affairs.
• Auditing experience in medical device, pharmaceutical, food, cosmetic, or personal products industries with a focus on quality management systems.

Culture & Benefits

• Competitive total rewards package with health insurance, life and disability coverage, 401(k) contributions, and paid time off for eligible employees.
• Continuing education and training opportunities.
• Inclusive workplace focused on belonging, diversity, career growth, and employee development.
• Employee Assistance Program, Employee Resource Groups, and Employee Service Corp access for eligible employees.