Quality Assurance Associate II (Medical Devices)

TL;DR

Quality Assurance Associate II (Medical Devices): Performing inspection and release of manufacturing goods for diabetes technology products with an accent on compliance with FDA regulations and GMP requirements. Focus on reviewing Design History Records, conducting routine verifications, and ensuring product quality through strict adherence to SOPs.

Location: On-site at Barnes Canyon, California

Salary: $22.50 - $24.00 per hour

Company

hirify.global creates new possibilities for people living with diabetes through innovative insulin delivery systems like the Tandem Mobi and t:slim X2.

What you will do

• Perform in-process and final inspections and approvals of manufacturing goods.
• Review and approve Design History Records (DHRs) and associated test reports.
• Resolve non-conformances occurring with in-process and finished products.
• Provide quality oversight of the manufacturing process and final packaging.
• Maintain departmental documentation and inventory of retained materials.
• Assist with internal and 3rd party audits.

Requirements

• Associate’s degree (Bachelor’s preferred).
• 5+ years of relevant quality/manufacturing experience in an FDA regulated industry, preferably medical devices.
• Experience with QSRs, QC testing methods, and GMP requirements.
• Proficiency in document review, lot release, and in-process inspection.
• Must be authorized to work in the U.S. (no sponsorship provided).
• Ability to stand, walk, and lift up to 45 lbs.

Culture & Benefits

• Medical, dental, and vision insurance available from the first day.
• Health Savings Accounts (HSA) and Flexible Saving Accounts (FSA).
• 11 paid holidays per year and a minimum of 20 days of PTO.
• 401k plan with company match.
• Employee Stock Purchase plan.