Quality System Specialist (Medtech)

TL;DR

Quality System Specialist (Medtech): Supporting the development, implementation, and maintenance of quality management systems with an accent on CAPA program management, audit readiness, and regulatory compliance. Focus on ensuring adherence to ISO 13485 and FDA standards while driving continuous improvement across cross-functional teams.

Location: Must be based in Lafayette, Colorado, United States

Salary: $75,200 – $112,800 USD

Company

hirify.global is a global leader in healthcare technology dedicated to alleviating pain, restoring health, and extending life for millions of patients worldwide.

What you will do

• Manage the CAPA program, including root cause investigations, action planning, and verification of effectiveness.
• Prepare and deliver reports and documentation for internal and external stakeholders.
• Support audit and inspection readiness, resolve findings, and act as a liaison with auditors.
• Interpret policies and regulations to ensure full compliance across the organization.
• Collaborate with R&D, Regulatory, Operations, and Supplier Quality teams to maintain the Quality Management System.
• Generate and analyze standard reports to monitor KPIs and identify performance patterns.

Requirements

• Bachelor's degree with at least 2 years of quality assurance experience in the medical device or pharmaceutical industry, or a Master's degree with 0 years of experience.
• Must possess unrestricted U.S. work authorization at the time of hire.
• Strong understanding of Quality Management Systems (QMS) and regulatory standards.
• Experience with CAPA, audits, and change control processes.
• Proficiency in Microsoft Office Suite.
• Ability to work independently and collaboratively across functions.

Nice to have

• Hands-on experience with TrackWise and Agile PLM systems.
• Knowledge of ISO 13485, FDA regulatory, EU MDR, and MDSAP requirements.
• Demonstrated continuous improvement mindset and process improvement methodology skills.

Culture & Benefits

• Comprehensive health, dental, and vision insurance.
• 401(k) plan with employer contribution and match.
• Paid time off and paid holidays.
• Tuition assistance and reimbursement programs.
• Employee Stock Purchase Plan and short-term incentive plans.
• Access to global well-being programs and employee assistance services.