Quality Assurance Specialist (Medical Devices)

Location: Carlsbad, California, United States

Salary: $80,000–$90,000 annual base salary

Company

hirify.global develops the aprevo® personalized surgery platform, proprietary implants, instrumentation, and design automation systems to improve outcomes and reduce the cost of spine surgery.

What you will do

• Plan and lead CAPA meetings, manage CAPAs in the electronic quality system, and track activities, approvals, and effectiveness.
• Lead root cause analysis meetings and develop, implement, and verify corrective action plans with subject matter experts.
• Plan audit schedules, assign auditors and subject matter experts, conduct audits, assess evidence, classify findings, and prepare reports.
• Coordinate customer, regulatory, internal, and third-party audits, including documentation, response follow-up, and records retrieval.
• Interpret regulatory and industry-standard changes, perform gap assessments, and revise corporate procedures for continued compliance.
• Support field actions and recalls, improve quality processes, and analyze quality and compliance metrics for management reviews.

Requirements

• Minimum three years of experience in the medical device industry and quality system management or quality assurance.
• Minimum two years of experience as a lead auditor.
• Working knowledge of 21 CFR 820, ISO 13485, MDSAP, and ISO 14971.
• Experience with CAPA administration, regulatory implementation, system-change compliance reviews, quality metrics, and third-party audit coordination.
• Advanced Excel skills, including VLOOKUP, pivot tables, forms, and data analysis, plus advanced PowerPoint skills.
• Effective technical writing and verbal communication skills; ISO 13485 Lead Auditor certification is preferred.

Nice to have

• Working knowledge of ISO 27001.
• Training or experience with root cause analysis tools.
• Experience implementing quality-system improvements such as ISO 13485:2016 upgrades or MDSAP.

Culture & Benefits

• Full-time employment with a comprehensive benefits package.
• 100% employer-paid medical, dental, and vision insurance premiums.
• 401(k) plan with employer matching.
• Unlimited paid time off.
• Incentive compensation programs may be available to eligible employees.