QA Systems Engineer (Medical Devices)

Location: Medina, New York, United States; onsite in a regulated manufacturing facility

Salary: $76,000–$104,500 annually, with potential discretionary bonuses

Company

hirify.global develops healthcare products and operates manufacturing facilities focused on improving patient care and sustaining lives.

What you will do

• Execute complex IQ, OQ, PQ, and MSA validation protocols and reports for processes, equipment, test methods, and computerized systems.
• Own and drive change control according to procedural requirements.
• Support or lead process improvement initiatives focused on scrap reduction, defect reduction, and new process or technology implementation.
• Present validation work and communicate with external auditors and project stakeholders.
• Collaborate with production, quality, laboratory, management, and engineering teams during process design, equipment installation, qualification, and monitoring.
• Prepare technical reviews, project documentation, reports, and data-driven analyses.

Requirements

• Bachelor’s degree in Engineering; 1–3 years of engineering experience preferred.
• Experience with technical communication, cross-functional collaboration, problem-solving, root cause analysis, and engineering principles.
• Understanding of validation guidelines, cGMP regulations, and Good Manufacturing Practices preferred.
• Strong multitasking, prioritization, learning, and deadline-management skills.
• Must be authorized to work for any employer in the United States; visa sponsorship is not available.
• Ability to work onsite in a regulated manufacturing environment and comply with cleanroom, ESD, FDA, and internal quality standards.

Nice to have

• Training or experience with Lean or Six Sigma process improvement methods.
• Interest in obtaining ASQ certifications.
• Manufacturing or medical device industry experience, including quality systems development and deployment.

Culture & Benefits

• Collaborative, accountable environment focused on courage, trust, and meaningful impact.
• Medical and dental coverage beginning on the first day for eligible employees.
• Life, accident, disability, and business travel accident insurance.
• 401(k) retirement plan with employee contributions and company matching, plus an employee stock purchase plan.
• Paid holidays, paid time off ranging from 20 to 35 days based on service, family and medical leave, and paid parental leave.
• Educational assistance, commuting and childcare benefits, employee discounts, and an employee assistance program.