Quality Assurance Specialist (Medical Devices)

Location: Fully remote within the United States, excluding Alaska and Hawaii; requires 3–4 trips per year for client or conference travel and the annual company retreat.

Salary: $100,000–$120,000 base salary, plus a 10% performance-based bonus.

Company

hirify.global is a remote-first medical device consultancy combining software engineering, AI/ML validation, cybersecurity, regulatory affairs, and quality management to help medical devices reach the market.

What you will do

• Lead Medtech OS implementations by assessing client needs, defining QMS scope, planning implementation, configuring the system, migrating content, and guiding launches.
• Build and remediate quality systems, including policies, SOPs, work instructions, records, and core processes aligned with ISO 13485 and FDA requirements.
• Support design controls, risk management, cybersecurity, document and change control, supplier quality, CAPA, complaints, audits, management reviews, reporting, recalls, and quality planning.
• Create and maintain audit-ready quality records, including quality manuals, training records, supplier files, DDFs, DMRs, and DHRs.
• Lead client working sessions and training, provide ongoing quality support, manage engagements, and communicate risks and decisions to technical and executive audiences.
• Conduct FDA and ISO 13485 gap assessments, support inspection readiness, improve Medtech OS workflows, and mentor quality team members.

Requirements

• At least 3 years of medical device quality assurance or quality systems experience, including hands-on QMS implementation, operation, or remediation.
• Experience completing at least one FDA inspection and strong knowledge of ISO 13485 and FDA medical device quality system requirements.
• Experience with core quality processes such as document control, training, supplier quality, design controls, risk management, CAPA, complaints, internal audits, and management reviews.
• Ability to independently lead client engagements, manage multiple workstreams, write clearly, and communicate with technical and executive audiences.
• Familiarity with software and Software as a Medical Device development, including IEC 62304 and ISO 14971.
• Ability to work remotely from the United States, excluding Alaska and Hawaii, with 3–4 annual trips.

Nice to have

• Experience leading an eQMS implementation, QMS migration, or major quality-system improvement project.
• Experience with AI/ML-enabled devices, Notion, or another eQMS platform.
• Consulting experience and a record of training or mentoring client teams.
• ASQ certification, ISO 13485 auditor credential, or a relevant advanced degree.

Culture & Benefits

• Fully remote work with flexible hours.
• Comprehensive paid time off package.
• Partial healthcare reimbursement plus vision and dental reimbursement.
• Automatic 3% contribution to a 401(k) retirement plan.
• Annual company retreat for team building and collaboration.

Hiring process

• Application review followed by interviews for strong matches.
• Short take-home exercise.
• Two reference checks.