Quality Investigator (Pharmaceutical Manufacturing)

Location: Onsite in Irvine, California, United States

Salary: $71,169–$89,000 per year

Company

hirify.global develops, manufactures, and markets medical products and services, including infusion therapy, pain management, nutrition, pharmacy compounding, wound care, and dialysis solutions.

What you will do

• Lead and document investigations into nonconformances, deviations, complaints, CAPA, and other quality events.
• Conduct root cause analysis using 5 Whys, Fishbone, Fault Tree, Pareto, DMAIC, and related methodologies.
• Evaluate quality data, manufacturing records, test results, and process trends to identify causes and contributing factors.
• Develop corrective and preventive actions, coordinate implementation, monitor progress, and verify effectiveness.
• Support internal, customer, and regulatory audits and maintain inspection readiness.
• Partner with Manufacturing, Engineering, Supply Chain, Supplier Quality, Regulatory Affairs, and Quality Operations teams on quality improvement.

Requirements

• Bachelor’s degree in Engineering, Quality, Life Sciences, Manufacturing, or a related technical field.
• At least 2 years of experience in Quality Assurance, Quality Engineering, Manufacturing Quality, or Quality Systems.
• Experience conducting investigations and root cause analysis in a regulated or manufacturing environment.
• Strong understanding of quality management systems, quality processes, problem-solving methods, and risk management.
• Strong technical writing, analytical, organizational, verbal, and written communication skills.
• Ability to manage multiple investigations simultaneously and meet established deadlines.

Nice to have

• Experience with nonconformance, CAPA, complaint, deviation, or electronic quality management systems.
• ASQ Certified Quality Engineer, Certified Quality Auditor, or related certification.
• Experience in medical device, pharmaceutical, biotechnology, aerospace, automotive, or another regulated industry.
• Familiarity with ISO 9001, ISO 13485, FDA QSR, statistical analysis tools, Excel, or Power BI.

Culture & Benefits

• Onsite work schedule in Irvine, California.
• Healthcare benefits and a 401(k) plan.
• Tuition reimbursement.
• Focus on continuous improvement, knowledge sharing, product safety, and regulatory compliance.