Quality Affairs Specialist (Medtech QMS)

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

Salary: $100,000–$120,000 per year, plus a 12% 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 market.

What you will do

• Lead Medtech OS and eQMS implementations, including current-state assessments, QMS scoping, configuration, content migration, launch planning, and adoption.
• Build and remediate quality systems with policies, SOPs, work instructions, records, and processes aligned with ISO 13485 and FDA quality system requirements.
• Implement and support core QMS activities, including design controls, risk management, cybersecurity, CAPA, supplier quality, complaints, audits, management reviews, and post-market processes.
• Establish audit-ready documentation such as quality manuals, training records, supplier files, change orders, audit schedules, DHFs, DMRs, and DHRs.
• Lead client workshops and training, manage multiple engagement workstreams, communicate risks and decisions, and translate quality requirements for technical and executive audiences.
• Perform FDA and ISO 13485 gap assessments, support inspection readiness, improve Medtech OS workflows, and mentor quality team members.

Requirements

• At least 3 years of experience in medical device quality assurance or quality systems, 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 several core quality processes, including document control, training, supplier quality, design controls, risk management, CAPA, complaints, internal audits, and management reviews.
• Ability to independently lead consulting engagements, manage multiple workstreams, write clearly and precisely, and communicate with technical and executive audiences.
• Familiarity with software or SaMD development, IEC 62304, ISO 14971, and configuring software tools.
• Must be based in the United States, excluding Alaska and Hawaii, and able to travel 3–4 times per year.

Nice to have

• Experience leading an eQMS implementation, QMS migration, or major quality-system improvement project.
• Experience with AI/ML-enabled medical devices, Notion, or another eQMS platform.
• Consulting experience and a track 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 focused on team building and collaboration.

Hiring process

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