Mfg/Ops Quality Engineer 1 (Medtech)

Location: San Diego, California, United States; onsite manufacturing environment

Base salary: $62,900–$94,300 per year, plus eligible variable cash compensation and equity

Company

hirify.global develops genomic technology that supports early disease detection, diagnosis, treatment discovery, and broader health equity.

What you will do

• Provide quality engineering support throughout the product lifecycle in manufacturing and operations.
• Support validation planning, transfer activities, verification and validation reports, and validation package quality.
• Review and manage nonconformances, QI/CAPA records, investigations, corrective actions, change orders, and equipment lifecycle activities.
• Support process risk management, technical discussions, issue resolution, and manufacturing capacity expansion.
• Trend, analyze, and report quality data to improve products and processes.
• Collaborate with Manufacturing, Process Engineering, and cross-functional teams across hirify.global sites.

Requirements

• Bachelor’s degree in engineering or science preferred.
• 0–2 years of quality assurance experience in a regulated environment.
• Knowledge of 21 CFR 820, ISO 13485, ISO 14971, and IVDD.
• Experience instituting quality controls in an ERP system; SAP experience preferred.
• Strong communication, facilitation, negotiation, and project management skills.
• Ability to work in a fast-paced environment with changing demands.

Nice to have

• Direct experience in in-vitro diagnostic manufacturing.
• Familiarity with applicable manufacturing technology and risk-based decision-making.

Culture & Benefits

• Inclusive environment focused on belonging, collaboration, openness, and diverse perspectives.
• Health, dental, and vision coverage, retirement benefits, paid time off, and family planning support.
• Access to genomics sequencing and Employee Resource Groups supporting career development and social responsibility.
• Eligible employees may receive variable cash compensation and equity.
• This role is not eligible for visa sponsorship.

Hiring process

• Employment is conditional on a background check.
• The position remains posted until a final candidate is selected or enough qualified applications are received.
• Generative AI is prohibited during the application and interview process.