Senior Quality Assurance Specialist (IVD)

Location: Newark, California, United States; onsite work required during standard business hours

Salary: $89,300–$146,900 per year

Company

hirify.global provides tools for life sciences and clinical diagnostics research to support the treatment and prevention of disease.

What you will do

• Manage document control activities using electronic databases and maintain quality records.
• Conduct internal audits, prepare audit reports, and support regulatory inspections.
• Review batch records, release approved materials, and place nonconforming materials on hold when required.
• Lead nonconformance investigations and CAPA activities, including Materials Review Board and CAPA Review Board meetings.
• Prepare quality indicators and management review data, and write and maintain QA SOPs.
• Write validation plans and reports and execute validation activities.

Requirements

• Bachelor’s degree in science, engineering, or a related field is strongly preferred.
• At least three years of experience in a quality assurance function.
• Experience with document control, QA regulations, quality best practices, CAPA, and nonconforming material investigations.
• Working experience as a lead auditor and the ability to prepare reports and determine material dispositions.
• Strong understanding of ISO 13485, FDA Quality System Requirements, and ISO 14971 risk management for IVD products.
• Ability to write validation protocols and reports, evaluate technical data, and use Microsoft Office and Excel for analysis and reporting.

Nice to have

• ASQ CQE, CQA, or Lead Auditor certification.
• Experience with electronic databases for document control.
• Basic knowledge of statistical techniques and sample size rationale.

Culture & Benefits

• Medical, dental, vision, life, disability, pet, and legal insurance benefits starting on the first day.
• 401(k), employee stock purchase plan, HSA, FSA, and dependent care FSA.
• Mentorship, training and development, tuition reimbursement, and promotional opportunities.
• Paid holidays, paid time off, paid parental leave, volunteer paid time off, and employee resource groups.
• Work in a laboratory and production environment with exposure to chemicals, reagents, and standard laboratory equipment.