Quality Engineer II (Manufacturing)

Location: Rochester, New York, US. Onsite work in manufacturing, labs, and offices at 1049 West Ridge Road.

Salary: $70,000–$90,000 base salary per year, with 2+ years of experience and an engineering degree.

Company

hirify.global provides medical imaging systems and solutions, X-ray imaging systems for non-destructive testing, and contract manufacturing services.

What you will do

• Provide hands-on quality engineering support for electromechanical assembly, testing, inspection, packaging, and service operations.
• Analyze product, process, supplier, and service quality data to identify trends, reduce defects, and improve process capability.
• Lead investigations into manufacturing defects, nonconforming materials, supplier issues, service failures, and customer complaints.
• Develop control plans, inspection plans, sampling methods, acceptance criteria, quality procedures, work instructions, and investigation reports.
• Plan and execute qualification, validation, measurement-system, and change-control activities for processes, equipment, software, test methods, products, and materials.
• Support supplier qualification, audits, quality-system compliance, employee training, and cross-functional quality initiatives.

Requirements

• Bachelor’s degree in quality, mechanical, electrical, industrial, manufacturing, biomedical, or a related engineering discipline.
• 2+ years of quality engineering experience in a regulated manufacturing environment.
• Working knowledge of ISO 13485 and experience applying quality-system, documentation, risk-management, and regulatory requirements.
• Experience investigating nonconformities, leading structured root-cause analysis, and implementing corrective and preventive actions.
• Experience analyzing manufacturing data and developing process controls, inspection plans, acceptance criteria, validation documentation, or related quality records.
• Strong analytical, project-management, written, and verbal communication skills.

Nice to have

• Experience in medical-device, diagnostic-equipment, radiographic-imaging, or other FDA-regulated manufacturing.
• Experience with electromechanical assembly, system-level testing, troubleshooting, returned-product analysis, installation, or service operations.
• Knowledge of ISO 9001, FDA Quality Management System Regulation, MDSAP, and medical-device risk management.
• Experience with process validation, equipment qualification, test-method validation, measurement-system analysis, statistical process control, process capability analysis, or design of experiments.
• ASQ Certified Quality Engineer, Lean Six Sigma, or ISO auditor certification or training.

Culture & Benefits

• Work across manufacturing, operations, supply chain, engineering, and regulatory functions.
• Work environment includes manufacturing areas, laboratories, and offices.
• Physical activity includes regular standing, walking, bending, and lifting requirements.
• Reasonable accommodations are available during the application process.

Hiring process

• Complete the online application process.
• Compensation is tailored within the stated range based on experience, industry knowledge, technical and communication skills, and geographic market factors.