Quality Assurance Associate II (Medtech)

Location: On-site four days a week at the San Diego office, United States. Schedule: 2:30 pm–1:00 am Pacific Time.

Salary: $22.50–$24.00 per hour.

Company

hirify.global develops and manufactures diabetes technology, including the Tandem Mobi system and t:slim X2 insulin pump with automated insulin delivery technology.

What you will do

• Perform in-process inspections, final inspections, and final product approvals.
• Review and approve Design History Records, test reports, manufacturing records, and 5S log sheets.
• Provide quality oversight for manufacturing and final packaging, including lot release activities.
• Investigate and help resolve non-conformances involving in-process and finished products.
• Maintain quality documentation, spreadsheets, statistics, retained-material inventory, and controlled procedures.
• Support calibration and preventive-maintenance checks, incoming inspections, internal audits, and third-party audits.

Requirements

• Associate’s degree or equivalent combination of education and applicable experience; a bachelor’s degree is preferred.
• At least five years of relevant quality or manufacturing experience in an FDA-regulated industry, preferably medical devices.
• Experience with QSRs, GMP requirements, QC testing methods, lot release, document review, and in-process inspection.
• Strong understanding of process controls, acceptance criteria, identification and traceability, and material segregation.
• Ability to communicate effectively and coordinate priorities across cross-functional teams.
• Proficiency with Microsoft Word, Excel, and Outlook. Applicants must already be authorized to work for any employer in the United States.

Culture & Benefits

• Temporary assignment through a staffing agency with potential conversion to regular full-time employment based on business need and performance.
• Temporary-assignment benefits may be provided by the staffing agency; Tandem-sponsored benefits are available after conversion.
• Health, dental, and vision coverage, plus health savings and flexible spending accounts.
• Eleven paid holidays, at least 20 days of paid time off, a 401(k) with company match, and an employee stock purchase plan after applicable eligibility.
• Pre-employment screening includes a drug test, excluding marijuana, and a background check.