Associate Quality Engineer (MedTech)

TL;DR

Associate Quality Engineer (MedTech): Supporting quality system processes for CLIA laboratories and CE-IVD products with an accent on regulatory compliance, CAPA management, and audit support. Focus on maintaining standards like ISO 13485 and FDA QSR while collaborating on product development projects.

Location: Must be based in the US

Company

hirify.global is a global leader in cell-free DNA testing, dedicated to oncology, women’s health, and organ health through personalized genetic diagnostics.

What you will do

• Support internal and external audits including CLIA/CAP and ISO 13485.
• Manage CAPA, deviations, change requests, and nonconformance investigations.
• Write and revise quality procedures and forms.
• Perform statistical analysis and hypothesis testing as required.
• Review manufacturing and QC batch records for compliance.
• Represent QA on product development projects.

Requirements

• Must be based in the US
• B.S. degree in science, engineering, or a related field.
• At least 4 years of experience in medical diagnostics, CLIA laboratory, or Life Sciences.
• Experience with internal, third-party, or regulatory audits.
• Knowledge of CLIA/CAP regulations, ISO 13485, and FDA QSR (21 CFR 820).
• Strong technical writing and communication skills.

Nice to have

• 2 years of experience in a dedicated Quality role.
• American Society of Quality (CQE) certification.
• Hands-on experience with DNA isolation, PCR, sequencing, or bioinformatics.

Culture & Benefits

• Comprehensive medical, dental, and vision insurance plans.
• 401k retirement benefits.
• Free genetic testing for employees and immediate family.
• Fertility care benefits and pregnancy/baby bonding leave.
• Generous employee referral program.