Quality Assurance Lead (MedTech)

TL;DR

Quality Assurance Lead (MedTech): Managing electronic Quality Management Systems (EQMS) and ensuring regulatory compliance for clinical laboratory services with an accent on FDA, CLIA, and GCLP standards. Focus on leading quality system processes, conducting internal/external audits, and supporting design controls for high-value transplant diagnostic solutions.

Location: Must be based in Brisbane, CA (Onsite)

Salary: $112,000–$140,000 USD

Company

hirify.global is a leading precision medicine company providing genomics-based information and digital healthcare solutions for transplant patients and caregivers.

What you will do

• Manage the electronic Quality Management System (EQMS) including system administration, user training, and troubleshooting.
• Lead quality system processes for CAPA, supplier qualifications, complaints, and non-conforming materials.
• Perform quality reviews of manufacturing batch records, procedures, and technical documentation.
• Support GCLP compliance and participate in internal and external regulatory audits.
• Provide guidance to cross-functional teams on quality requirements and design controls for Laboratory Developed Tests (LDT).

Requirements

• Bachelor of Science degree in a scientific field.
• 5-8 years of experience in Quality Assurance within a regulated environment.
• Strong knowledge of FDA/QMSR and CLIA regulations.
• Experience with document control databases and administrator responsibilities.
• Demonstrated ability to present quality metrics and findings to upper management.
• Must be authorized to work in the United States.

Nice to have

• Experience with CAP, NY State audits, and inspections.
• Background in PCR, RUO, or IVD sequencing assays.
• Experience in a CLIA-regulated laboratory environment.

Culture & Benefits

• Competitive base salary with incentive compensation and restricted stock units.
• Comprehensive health and welfare benefits including gym reimbursement.
• 401(k) savings plan with company match.
• Employee Stock Purchase Plan and pre-tax commuter benefits.
• Living Donor Employee Recovery Policy providing up to 30 days of paid leave.