Principal Quality Engineer (Pharmaceutical Manufacturing)

Location: Northfield, Illinois, United States. The position requires travel up to 30% for domestic and international business purposes.

Salary: $116,000–$174,000 annually, with bonus and/or incentive eligibility.

Company

hirify.global is a growing worldwide healthcare organization offering medical and pharmaceutical products and quality-focused operations.

What you will do

• Lead quality projects and collaborate with cross-functional teams across corporate divisions and manufacturing sites.
• Own and maintain the Management Review program in alignment with ICH Q10, corporate quality standards, and site procedures.
• Collect and analyze PQS performance data, including deviations, CAPAs, complaints, recalls, audits, validation status, change controls, metrics, and regulatory commitments.
• Facilitate management review meetings and prepare reports and dashboards covering trends, risks, improvement opportunities, and quality system effectiveness.
• Lead root-cause investigations, corrective and preventive actions, QMS improvements, cost-of-quality initiatives, and risk management activities.
• Support inspection readiness, regulatory compliance, and escalation of significant quality and business risks to leadership.

Requirements

• Bachelor’s degree in mechanical, biomedical, electrical, or software engineering, or a related science.
• At least 7 years of experience in pharmaceutical manufacturing, medical device engineering, and/or quality assurance; 10 years preferred.
• Experience leading projects, managing competing priorities, driving process and QMS improvements, and communicating with senior and executive audiences.
• Knowledge of auditor expectations, objective evidence, compliance gap assessment, statistical techniques, and data-driven decision-making.
• Preferred knowledge of ICH Q10, FDA cGMP regulations including 21 CFR Parts 210/211, EU GMP, and inspection expectations.
• Experience with CAPA, deviations, change control, complaints, audits, Management Review, disconnected data sources, and regulatory inspections.

Culture & Benefits

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