Quality Assurance Manager (Medical Devices)

Location: Hybrid, Dallas, Texas, United States; primarily office-based with occasional production-floor interaction and travel for supplier audits or regulatory engagements.

Company

hirify.global develops people-centric technologies for venous and lymphatic care that support self-care and improve patient lives.

What you will do

• Lead the implementation, maintenance, and continuous improvement of the Quality Management System (QMS), including document control, change control, KPIs, CAPA, management reviews, and validation activities.
• Maintain Device Master Records, Design History Files, quality procedures, and regulatory documentation.
• Lead internal audits and prepare for and manage external audits and regulatory inspections.
• Own complaint handling, including investigations, documentation, closure, medical device reporting decisions, FDA MDR submissions, and post-market surveillance trending.
• Oversee ISO 14971 risk management, supplier qualification and monitoring, supplier audits, and supplier-related quality risk mitigation.
• Develop quality training programs, maintain training records and competency matrices, lead continuous improvement initiatives, and manage and coach quality staff.

Requirements

• Bachelor’s degree in Engineering, Quality Management, Life Sciences, or a related field, or an equivalent combination of education and experience in a Quality Management role.
• 5+ years of experience in Quality Systems, Quality Assurance, or Regulatory Compliance in the medical device industry or another FDA-regulated manufacturing environment, including at least 2 years in a leadership role.
• Strong expertise in FDA 21 CFR Part 820, ISO 13485:2016, and ISO 14971 requirements.
• Experience with QMS management, CAPA, document control, internal audits, complaint handling and MDR reporting, nonconforming material, and risk management.
• Hands-on experience administering an electronic QMS or PLM platform; Arena is preferred.
• Excellent organizational, analytical, and problem-solving skills.
• Strong leadership and communication skills with cross-functional collaboration experience.
• Ability to work primarily in an office, interact occasionally on the production floor, travel as needed, and occasionally lift or move up to 25 pounds, with reasonable accommodations available.

Nice to have

• Certified Quality Auditor (CQA), Six Sigma, or ASQ certification.
• Expertise in regulatory submissions, external audits, and notified body interactions.
• Experience supporting an ERP implementation or migration in a regulated manufacturing environment.

Culture & Benefits

• Fast-paced environment focused on transforming venous and lymphatic care through innovative technologies.
• Values include integrity, humility, hard work, camaraderie, fun, collaboration, continuous improvement, problem solving, and change agility.
• Base plus bonus compensation package.
• Competitive benefits program.
• Full-time, exempt employment with opportunities to lead, develop, and coach team members.