Site Quality Assurance Engineer II (Medical Devices)

Location: Hybrid or on-site, with regular presence at a manufacturing or operational facility and occasional travel

Annual salary: $97,000–$120,000 USD, plus eligibility for an annual bonus.

Company

hirify.global develops medical devices, software, and related services for diagnosing and treating serious cardiopulmonary and respiratory conditions. The Acute Care Technology division serves EMS, hospital, public safety, and military customers worldwide.

What you will do

• Lead investigations into manufacturing and process quality issues, including root cause analysis, data review, recommendations, and corrective-action follow-up.
• Support Material Review Board activities and resolve nonconforming materials through documentation, disposition support, and cross-functional coordination.
• Analyze yield, scrap, rework, and process capability data to identify trends and manufacturing quality improvement opportunities.
• Support process validation, equipment qualification, and new product introduction readiness through documentation reviews and quality assessments.
• Collaborate with Manufacturing, Operations, Engineering, Supply Chain, Supplier Quality, and Regulatory teams to resolve site quality issues.
• Participate in internal and external audits, inspection readiness, regulatory compliance activities, and continuous improvement initiatives.

Requirements

• Bachelor’s degree in Engineering or a related technical discipline.
• At least 5 years of experience in quality engineering, manufacturing quality, or a related engineering role.
• Experience leading investigations, root cause analysis, manufacturing quality improvement, nonconformance management, and CAPA activities.
• Knowledge of statistical process control, process capability analysis, data-driven problem solving, and manufacturing quality methodologies.
• Familiarity with FDA Quality System requirements, ISO 13485, and medical device regulatory requirements.
• Advanced English proficiency and ability to work in a hybrid or on-site environment are required.

Nice to have

• Experience in medical device manufacturing, process validation, equipment qualification, and new product introduction support.
• ASQ Certified Quality Engineer or similar certification.

Culture & Benefits

• Work focused on improving patient outcomes and supporting lifesaving cardiopulmonary technologies.
• Regular on-site collaboration with occasional travel for training, audits, investigations, or multi-site support.
• Annual bonus eligibility and comprehensive benefits plans.
• Culture emphasizing innovation, self-motivation, and an entrepreneurial spirit.