Quality Assurance Technician II (Medical Devices)

Location: Chattanooga, Tennessee, United States; onsite role

Company

hirify.global develops and manufactures medical devices and components, including Nitinol components, stents, catheters, biomedical textiles, and precision polymer tubing.

What you will do

• Review manufacturing and quality documentation to authorize product release for shipping and final customer release.
• Support calibration management, quality documentation compliance, DCOs, ECOs, validation protocols, and validation reports.
• Support quality engineering through sampling-plan reduction, statistical analysis, and resolution of complex quality issues.
• Conduct or support internal and external audits, root cause investigations, and quality improvement activities.
• Coordinate or technically supervise inspectors, operators, and other personnel supporting assigned work.
• Follow safety and quality procedures and contribute to departmental KPIs.

Requirements

• High-school diploma required; a college degree is preferred.
• Two to three years of experience in the medical industry is preferred, with medical device experience considered an asset.
• Intermediate to advanced Excel skills, along with proficiency in Microsoft Office, Windows, email, databases, and electronic record keeping.
• Strong accuracy, attention to detail, documentation, analytical, problem-solving, confidentiality, and multitasking skills.
• Training or knowledge in ISO 9001/13485, FDA Part 820, technical writing, FMEA, process validation, statistics, quality engineering, or quality management is an asset.
• Must already have unrestricted employment authorization in the United States; employment visa sponsorship is not available and time-limited visa holders will not be considered.

Nice to have

• Knowledge of Minitab, Six Sigma, sterilization, or statistical quality methods.
• Experience supporting audits, validation, calibration, or medical device manufacturing.

Culture & Benefits

• Collaborative, high-impact environment focused on life-saving medical solutions.
• Competitive pay and benefits.
• Opportunities to support products from rapid prototyping through high-volume production.
• Strong emphasis on safety, quality, teamwork, and continuous improvement.