Sr Quality Assurance Specialist

Location: Remote in the United States

Company

hirify.global provides clinical genetics and laboratory services focused on patient care, regulatory compliance, and operational quality.

What you will do

• Execute and oversee assigned elements of the Quality Management System and improve related SOPs, policies, forms, and controls.
• Lead complex investigations of nonconformances, deviations, errors, complaints, and other quality events.
• Perform root cause analysis using methods such as 5 Whys, Fishbone, process mapping, and data analysis.
• Develop, manage, and evaluate CAPAs to address systemic causes and prevent recurrence.
• Lead or support internal, supplier, customer, and regulatory audits, including CAP, CLIA, FDA, and NYS inspections.
• Develop quality metrics, analyze trends and risks, and present actionable recommendations to Quality and cross-functional leadership.

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.
• Experience with quality investigations, root cause analysis, CAPA, quality event management, audits, and regulatory or accreditation requirements.
• Understanding of clinical and/or laboratory testing, quality management principles, and risk-based thinking.
• Experience writing, reviewing, and editing SOPs and other quality documentation.
• Proficiency with Microsoft Office, Smartsheet, and SharePoint, along with strong analytical, written, verbal, and organizational skills.

Nice to have

• Experience with ISO 15189 and ISO 13485.

Culture & Benefits

• Remote work arrangement within the United States.
• Cross-functional collaboration with Laboratory Operations, Clinical, Medical, Regulatory, IT, Product, and Customer Experience teams.
• Opportunity to mentor Quality Specialists and contribute to quality training and knowledge sharing.
• Work focused on patient safety, regulatory compliance, operational performance, and customer experience.