Senior Quality Assurance Specialist

Location: Austin, Texas, United States; onsite role

Salary: $78,100–$128,500 per year

Company

hirify.global enables life sciences and clinical diagnostics research by providing tools that support the treatment and prevention of disease.

What you will do

• Maintain and continuously improve Asuragen’s Quality Management System in alignment with international quality and regulatory standards.
• Lead compliance activities covering ISO 13485, FDA QMSR, MDSAP, IVDR, and related requirements.
• Execute QA production reviews, approvals, product release, validation reviews, and controlled equipment record approvals.
• Represent QA in new product design and development teams and lead external audits.
• Manage quality systems including training, NCR, CAPA, complaints, internal audits, supplier management, and document control.
• Lead Quality Management Reviews, communicate risks, develop mitigation plans, and train new QA team members.

Requirements

• Bachelor’s degree in a related field with 7–10 years of experience in a regulated manufacturing facility, or a comparable combination of education and experience.
• Alternatively, a master’s degree in a related field with 4–6 years of experience in a regulated manufacturing facility, or a comparable combination of education and experience.
• Experience with QA principles, regulated manufacturing, audits, quality reviews, statistical tools, and cross-functional project leadership.
• Strong analytical, problem-solving, communication, documentation, training, and dispute-resolution skills.
• Knowledge of molecular science fundamentals, cGMP, ISO 13485, MDSAP, IVDD/IVDR, and FDA QMSR is preferred.
• Must have U.S. work authorization that does not now or in the future require visa sponsorship.

Culture & Benefits

• Medical, dental, vision, life, disability, pet, legal, and identity protection insurance benefits begin on day one.
• 401(k), employee stock purchase plan, HSA, FSA, and dependent care FSA are available.
• Mentorship, promotional opportunities, training and development, and tuition reimbursement support career growth.
• Paid holidays, accrued paid time off, paid parental leave, and volunteer paid time off are offered.
• Employee resource groups, events, charity drives, and an empowerment-focused culture support belonging and innovation.