Quality Associate II (Pharmaceutical Quality Systems)

Location: Round Lake, Illinois, United States

Salary: $88,000–$121,000 annually, with potential discretionary bonuses

Company

hirify.global develops healthcare products and solutions focused on its mission to save and sustain lives.

What you will do

• Lead routine quality investigations, perform root cause analysis, and develop corrective and preventive actions.
• Assess proposed changes for regulatory, product quality, and compliance impact and coordinate cross-functional approvals.
• Prepare QMS metrics, dashboards, management review materials, and trend reports.
• Write, review, and revise SOPs, work instructions, and quality system documentation.
• Support internal, corporate, and regulatory audits and maintain inspection-ready records in eQMS platforms.
• Drive continuous improvement and collaborate with Manufacturing, Engineering, QC, Regulatory Affairs, and other stakeholders.

Requirements

• Bachelor’s degree in science, engineering, pharmacy, life sciences, quality, or a related technical discipline.
• At least 3 years of experience in Quality Assurance, Quality Systems, Quality Engineering, or Compliance within a regulated pharmaceutical, biotech, or medical device environment.
• Hands-on experience with change control, CAPA, complaints, nonconformance, deviations, or audit support.
• Knowledge of FDA regulations, including 21 CFR 210/211 and 21 CFR Part 820, ISO 13485, cGMP, and QMS requirements.
• Experience with root cause analysis tools, corrective action development, eQMS platforms, and technical quality documentation.
• Must be authorized to work for any employer in the United States; visa sponsorship is not available. Must not be allergic to penicillins or cephalosporins.

Nice to have

• Experience preparing quality metrics, trend reports, or management review materials.
• Experience supporting FDA, ISO, or other regulatory inspections.
• Experience in pharmaceutical or sterile manufacturing.

Culture & Benefits

• Collaborative quality organization balancing independent work with cross-functional teamwork.
• Medical and dental coverage beginning on day one, plus life, disability, and accident insurance.
• 401(k) retirement plan with company matching and employee stock purchase plan.
• Paid holidays, 20–35 days of paid time off based on service length, family and medical leave, and paid parental leave.
• Educational assistance, flexible spending accounts, commuting benefits, childcare benefits, and employee assistance programs.