Quality Specialist I (Medtech)

TL;DR

Quality Specialist I (Medtech): Providing hands-on quality support to manufacturing operations with an accent on regulatory compliance and documentation integrity. Focus on reviewing batch records, supporting investigations, and ensuring adherence to FDA and GMP standards in a pharmaceutical manufacturing environment.

Location: Must be based in Irvine, California, United States (Onsite role).

Salary: $90,000–$107,000 annually.

Company

hirify.global is a global leader in infusion therapy, pain management, and medical technology, committed to enhancing patient and clinician safety through innovative healthcare solutions.

What you will do

• Complete electronic and paper-based batch record reviews to support product release.
• Review SOPs, protocols, and reports to ensure accuracy and regulatory compliance.
• Support deviations, investigations, and CAPA processes using systems like TrackWise.
• Ensure data integrity and completeness across all quality documentation.
• Provide oversight for equipment and software qualification, validation, and calibration.
• Partner with cross-functional teams to maintain standardized quality processes.

Requirements

• Bachelor’s degree or equivalent experience in a related field.
• 4+ years of experience in quality, manufacturing, or a regulated environment.
• Proficiency with quality and business systems including TrackWise, LIMS, and ERP.
• Strong understanding of GMP and FDA regulatory requirements.
• Ability to work onsite in Irvine, California.

Culture & Benefits

• Comprehensive healthcare coverage.
• 401(k) retirement plan.
• Tuition reimbursement program.
• Commitment to professional development and Sharing Expertise philosophy.
• Stable work environment in a global medical technology organization.