Quality Specialist II

TL;DR

Quality Specialist II (MedTech): Providing oversight of the Quality System to ensure compliance with regulatory standards and internal procedures with an accent on documentation review, data integrity, and manufacturing process adherence. Focus on supporting batch release, managing investigations, and overseeing equipment qualification in a regulated pharmaceutical environment.

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

Salary: $96,000–$118,000 annually

Company

hirify.global is a global leader in infusion therapy, pain management, and medical technology, dedicated to improving patient and clinician safety through innovative healthcare products.

What you will do

• Provide quality oversight of the Quality System, including SOPs, protocols, and manufacturing records.
• Perform timely review of data and documentation to support batch release.
• Ensure strict compliance with FDA, ICH, and internal quality standards.
• Review records to guarantee data integrity and accuracy.
• Support and approve investigations and review associated reports.
• Oversee equipment and software qualification, calibration, and validation activities.

Requirements

• Bachelor’s degree or equivalent combination of education and experience.
• Minimum of 6 years of experience in a regulated industry.
• Strong knowledge of quality systems, regulatory requirements, and data integrity principles.
• Ability to work independently with general supervision.
• Excellent problem-solving, organizational, and communication skills.

Nice to have

• Relevant industry certifications.

Culture & Benefits

• Comprehensive healthcare coverage.
• 401(k) retirement plan.
• Tuition reimbursement program.
• Commitment to continuous improvement and professional development.
• Collaborative environment focused on global healthcare innovation.