Sr. Quality Engineer (Medical Devices)

Location: Onsite in Dallas, Texas, United States; full-time, 40 hours per week, Monday–Friday.

Company

hirify.global is a global specialty materials manufacturer producing engineered solutions for filtration, healthcare, sustainable packaging, and other applications.

What you will do

• Lead quality improvement initiatives by identifying bottlenecks, root causes, and corrective and preventive actions.
• Develop and maintain CAPAs, quality metrics, product specifications, quality plans, risk analyses, and FMEAs.
• Implement process monitoring systems to reduce variation, scrap, nonconforming material, and customer complaints.
• Analyze quality data, identify trends, and recommend corrective actions using statistical methods.
• Coordinate quality issue resolution with production, process engineering, regulatory, and other internal teams.
• Support regulatory, notified body, and client audits; assess findings and ensure compliance with applicable standards.

Requirements

• Bachelor’s degree or foreign equivalent in Computer Engineering, Systems Engineering, Industrial Engineering, or a related field.
• Eight years of relevant quality engineering or quality systems experience.
• Experience with quality assurance, auditing, IQ/OQ/PQ validation, CAPA, root-cause analysis, FMEA, DOE, fault-tree analysis, and structured problem-solving.
• Knowledge of SPC, control charts, capability analysis, Pareto and trend analysis, gauge R&R, sampling plans, Minitab, and Excel.
• Experience with QMS frameworks and elements including Design Controls, Non-Conformances, CAPA, Complaint Handling, and Document Control.
• Experience applying FDA, ISO 13485, 21 CFR Part 820, 21 CFR Part 210/211, 21 CFR Part 11, cGMP, and other standards for medical devices, OTC drugs, or cosmetics.

Culture & Benefits

• Medical, dental, and vision insurance with CDHP, PPO, and EPO options.
• Company-paid basic life insurance and additional voluntary life coverage.
• Paid vacation and personal time off.
• 401(k) savings plan with company match.
• Employee assistance, wellness, work-life support, career development, and educational assistance.