Quality Assurance Associate II (Medtech)

TL;DR

Quality Assurance Associate II (Medtech): Performing inspection and release of manufacturing goods for insulin delivery systems with an accent on compliance with FDA regulations and GMP standards. Focus on conducting in-process and final product verification, reviewing Design History Records, and ensuring quality oversight in a regulated manufacturing environment.

Location: Must be based on-site at our Barnes Canyon office (San Diego, CA)

Salary: $22.50 - $24.00 per hour

Company

hirify.global is a leader in diabetes technology, dedicated to creating innovative products like the Tandem Mobi system and t:slim X2 insulin pump to improve the lives of people with diabetes.

What you will do

• Perform in-process and final inspection of manufacturing goods to ensure compliance with Quality Test Procedures.
• Review and approve manufacturing Design History Records (DHRs) and associated test reports.
• Provide quality oversight of manufacturing processes and final packaging.
• Assist with internal and 3rd party audits to ensure regulatory compliance.
• Maintain department documentation, statistics, and inventory of retained materials.
• Support calibration and preventive maintenance programs for manufacturing equipment.

Requirements

• Must be authorized to work for any employer in the U.S. (no visa sponsorship available).
• Must be able to work on-site in San Diego, CA, Friday through Sunday (5 am - 5:30 pm).
• Associate’s degree or equivalent combination of education and experience.
• 5+ years of relevant quality or manufacturing experience in an FDA-regulated industry.
• Deep understanding of GMP regulations, Process Controls, and QC testing methods.
• Proficiency with MS Office suite (Word, Excel, Outlook).

Culture & Benefits

• Comprehensive health care benefits including medical, dental, and vision starting on day one.
• Access to 401k plan with company match and Employee Stock Purchase plan.
• 11 paid holidays per year and a minimum of 20 days of paid time off.
• Supportive workplace culture that values innovation, people-first approaches, and inclusivity.