Quality Engineer III (Manufacturing)

Location: Rochester, NY, US; onsite manufacturing production and laboratory environment

Salary: $90,000–$120,000 base salary per year

Company

hirify.global provides medical imaging systems and solutions, x-ray imaging systems for nondestructive 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 and maintain control plans, inspection plans, sampling methods, acceptance criteria, 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.
• At least 4 years of quality engineering experience, preferably in a regulated manufacturing environment.
• Working knowledge of ISO 13485 and experience applying quality-system, documentation, risk-management, and regulatory requirements.
• Experience with structured root-cause analysis, nonconformity investigations, and 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 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, measurement-system analysis, statistical process control, process capability analysis, or design of experiments.
• ASQ Certified Quality Engineer, Lean Six Sigma certification, or ISO auditor certification or training.

Culture & Benefits

• Work takes place in manufacturing production and laboratory settings.
• Physical activity includes standing, walking, bending, and carrying, pushing, or pulling materials.
• Regular lifting requirements range from 20 to 50 pounds.
• Reasonable accommodations are available during the application process.

Hiring process

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