Advanced Quality Assurance Specialist (Medical Devices)

Location: Austin, TX, United States; onsite role

Salary: $55,600–$91,450 per year

Company

hirify.global provides tools that support life sciences research and clinical diagnostics, helping researchers treat and prevent disease.

What you will do

• Maintain and expand Asuragen’s quality management system in line with international quality and regulatory standards.
• Provide quality assurance support to project core teams and own or support key quality management system processes.
• Conduct internal and external audits, summarize findings, and support Quality Management reviews.
• Manage or support document control, training, nonconformance, CAPA, complaints, internal audit, and supplier management systems.
• Review and approve validation activities, equipment calibrations, and maintenance.
• Generate quality metrics and support regulatory and client audits.

Requirements

• Bachelor’s or master’s degree in a related field, or a combination of education and applicable experience.
• 4–6 years of experience in a regulated manufacturing facility.
• Knowledge of quality assurance principles in a dynamic manufacturing environment.
• Experience with Microsoft Office and database management software.
• Strong document review, analytical, problem-solving, communication, prioritization, and deadline-management skills.
• Must have U.S. work authorization that does not now or in the future require visa sponsorship.

Nice to have

• Knowledge of cGMP, ISO 13485, MDSAP, IVDD/IVDR, and FDA QSR.
• Familiarity with statistical tools and concepts in regulated environments.
• Experience training employees on procedures, processes, and quality assurance concepts.

Culture & Benefits

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