Sr Quality Assurance Specialist

Location: Hybrid in Houston, Texas, USA

Company

hirify.global provides clinical laboratory and genetics services focused on patient safety, regulatory compliance, and customer experience.

What you will do

• Execute and oversee assigned elements of the Quality Management System and improve SOPs, policies, forms, and quality processes.
• Lead complex investigations of nonconformances, deviations, errors, complaints, and other quality events.
• Perform root cause analysis, develop and manage CAPAs, and evaluate corrective-action effectiveness.
• Lead or support internal, supplier, customer, and regulatory audits and coordinate responses through closure.
• Develop quality metrics, dashboards, reports, and recommendations based on trend and risk analysis.
• Partner with Laboratory Operations, Clinical, Medical, Regulatory, IT, Customer Experience, and other functions while mentoring Quality Specialists.

Requirements

• Master’s degree in Life Sciences, Biological Sciences, Medical Technology, Quality, Healthcare, or a related field plus 3 years of quality experience in a clinical laboratory setting; or a bachelor’s degree plus 6 years of relevant experience.
• In-depth knowledge of CLIA, CAP, and NYS standards and regulations.
• Demonstrated experience with quality investigations, root cause analysis, CAPA, quality event management, audits, and regulatory or accreditation requirements.
• Experience analyzing quality data, identifying trends, writing and reviewing SOPs, and applying risk-based quality management principles.
• Proficiency with Microsoft Office, Smartsheet, and SharePoint, with strong written, verbal, analytical, and organizational skills.
• Ability to work in a hybrid arrangement in Houston, Texas.

Nice to have

• Experience with ISO 15189 and ISO 13485.
• Experience with clinical and/or laboratory testing.

Culture & Benefits

• Cross-functional collaboration across laboratory, clinical, regulatory, technology, product, and customer experience teams.
• Opportunity to influence stakeholders and drive accountability without formal authority.
• Participation in quality management meetings, strategic initiatives, and organization-wide knowledge sharing.
• Work environment includes sitting, standing, computer use, and occasional exposure to bloodborne or airborne pathogens or infectious materials.
• Equal opportunity workplace with accommodations available during the application process.