Sr. Quality Engineer - Sterilization (Medical Devices)

Location: On-site five days a week at the Barnes Canyon office in California, United States

Starting base pay: $110K–$121K annually, excluding bonus and benefits.

Company

hirify.global develops and manufactures diabetes technology, including insulin pumps and automated insulin delivery systems.

What you will do

• Lead quality activities for sustaining engineering, production, product launches, and quality systems.
• Lead and support sterilization validation, including dose establishment, dose audits, requalification, routine monitoring, and supplier oversight.
• Manage cleanroom environmental control programs, qualification, requalification, contamination control, and environmental monitoring.
• Investigate sterilization and cleanroom nonconformances, contamination events, excursions, and adverse trends, including root cause analysis and corrective actions.
• Review and approve product, process, equipment, environmental monitoring, and change-control documentation.
• Support risk assessments, CAPA, NCRs, audits, process capability analysis, design reviews, validation testing, and cross-functional process improvement.

Requirements

• Bachelor’s degree in a technical field, preferably Mechanical Engineering, or equivalent education and experience.
• 5+ years of Quality Engineering experience in an FDA-regulated hardware, medical device, or similar regulated environment.
• Proficiency with ISO 13485, FDA QMSR, ISO 14971, ISO 11137, ISO 11737, AAMI ST72, and ISO 14644 standards.
• Experience with sterilization, bacterial endotoxin testing, cleanroom standards, statistical techniques, SPC, capability analysis, and quality metrics.
• Experience with root cause and problem-solving methods, mechanical drawings, GD&T, quality measurement equipment, and nonconformance identification.
• Applicants must already be authorized to work for any employer in the United States; visa sponsorship is not available.

Nice to have

• Experience working in an ISO environment.

Culture & Benefits

• Full-time employment with a competitive compensation package, bonus, and benefits.
• Work in a patient-focused medical technology organization committed to product quality and safety.
• Pre-employment drug screening and background check are required.
• Equal opportunity and inclusive workplace practices.