Quality Associate II (Audit)

Location: Round Lake, Illinois, United States. Applicants must be authorized to work for any employer in the U.S.; visa sponsorship is not available.

Estimated base salary: $88,000–$121,000 annually, with possible discretionary bonuses.

Company

hirify.global develops and manufactures healthcare products focused on saving and sustaining lives.

What you will do

• Maintain compliance audit quality systems in line with applicable regulatory requirements.
• Manage CAPA tracking, adequacy reviews, verification, closeout, and trend reporting for audits.
• Prepare and conduct internal and supplier audits by researching background information, defining assessment strategies, and analyzing objective evidence.
• Report audit and inspection findings, evaluate audit responses and CAPA plans, determine root causes, and escalate issues when appropriate.
• Support regulatory inspections, state licensing, regulatory intelligence, customer audits, and inspection-readiness activities.
• Prepare compliance trend reports and mentor Quality Compliance Associates I and Technicians on audit methodology.

Requirements

• At least 3 years of Quality experience in a medical device, pharmaceutical, or similarly regulated industry.
• At least 3 years of quality auditing experience in cGMP environments, including internal or external auditing.
• Bachelor’s degree in business, science, or an equivalent qualification.
• Working knowledge of applicable quality and regulatory standards, GMP regulations, and regulatory inspection processes.
• Strong communication, analytical, organizational, risk-assessment, and project leadership skills.
• Applicants must not be allergic to penicillins or cephalosporins.

Nice to have

• ASQ CQA or another auditor accreditation.
• General knowledge of Lean Six Sigma and continuous improvement tools.

Culture & Benefits

• Collaborative quality organization with opportunities to work independently and with plant or office teams.
• Medical and dental coverage starting on day one for eligible employees.
• Life, disability, and business travel accident insurance.
• 401(k) retirement plan with employee contributions and company matching, plus an employee stock purchase plan.
• Paid holidays, paid time off, family and medical leave, and paid parental leave.
• Educational assistance, flexible spending accounts, commuting benefits, childcare benefits, and employee assistance programs.