Quality Engineer (MedTech)

TL;DR

Quality Engineer (MedTech): Supporting early to late-stage laboratory development and IVD test compliance with an accent on quality system documentation, CAPA management, and regulatory audits. Focus on maintaining compliance with FDA, ISO 13485, and HIPAA standards while performing risk assessments and process monitoring in a fast-paced environment.

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

• Develop and implement quality system documentation, including SOPs and work instructions.
• Manage compliance activities such as non-conformances, CAPA, and audit investigations.
• Conduct internal and external audits to ensure adherence to FDA, ISO 13485, and HIPAA regulations.
• Perform risk assessments (FMEA, FTA) and monitor laboratory process workflows.
• Implement Statistical Process Control (SPC) and perform data analysis for test method validation.
• Provide expertise on healthcare data privacy regulations and maintain PHI security practices.

Requirements

• Must be based in the US
• B.S. degree in science, engineering, or a related field.
• 2–5 years of experience in quality process improvement within a regulated environment (FDA, ISO 13485, GMP, GLP, GCP, or HIPAA).
• Strong technical writing and communication skills.
• Ability to work independently and manage multiple projects in an intense environment.
• Proficiency with MS Office suite.

Nice to have

• American Society of Quality certifications (CQE, CMQ/OE).
• Hands-on experience with DNA isolation, PCR, sequencing, or bioinformatics.
• Extensive experience with ISO 14971.

Culture & Benefits

• Comprehensive medical, dental, and vision insurance plans.
• 401k retirement benefits and generous employee referral program.
• Free genetic testing for employees and immediate family members.
• Fertility care benefits and pregnancy/baby bonding leave.
• Commitment to a diverse, inclusive workplace and equal opportunity employment.