Quality Assurance Specialist III (FDA/ISO/GMP)

Location: Bozeman, Montana, USA; onsite at 625 Zoot Way

Salary: $24.64–$30.77 per hour, plus an annual 10% bonus opportunity.

Company

hirify.global manufactures and sells biological and chemical indicators that assess sterilization and disinfection effectiveness for pharmaceutical, healthcare, and dental industries.

What you will do

• Develop and implement quality assurance and compliance strategies for products, services, and processes.
• Lead complex product, process, and system audits while overseeing audit teams and schedules.
• Act as a subject matter expert on FDA, ISO, GMP, and other applicable regulatory requirements.
• Drive quality process improvements, operational efficiency initiatives, and risk mitigation activities.
• Develop and oversee corrective and preventive action plans for non-compliance and quality issues.
• Train and mentor quality teams and collaborate with R&D, Manufacturing, and Supply Chain.

Requirements

• Bachelor’s degree in Quality Management, Engineering, Life Science, or a related field.
• At least 5 years of experience in quality assurance or a related field.
• Deep knowledge of quality assurance principles, regulatory requirements, and industry standards.
• Experience managing complex compliance projects and leading teams.
• Strong analytical, problem-solving, leadership, communication, and interpersonal skills.
• Ability to manage multiple high-priority projects and work independently in a fast-paced environment.

Culture & Benefits

• Medical, dental, and vision insurance options, with benefits eligibility beginning the first day of the month after starting.
• Health savings, healthcare, and dependent care flexible spending accounts.
• Three weeks of accrued vacation, 48 hours of paid sick leave annually, and nine paid company holidays.
• Company-paid disability, life insurance, and AD&D coverage.
• 401(k) plan with a 4% Safe Harbor company match beginning on Day 1.
• Overtime opportunities and wellness and financial assistance resources.