Product Quality Engineer II

Location: Hybrid role in Cranberry Township, Pennsylvania, United States; office environment with up to 25% travel.

Base compensation: $75,000–$95,000 per year.

Company

hirify.global develops products and services supported by regulated product quality and lifecycle processes.

What you will do

• Execute defect management and engineering escalation processes and provide quality support throughout the product lifecycle.
• Lead product change control, coordinate cross-functional meetings, track actions and metrics, and maintain Device Master Records.
• Review design and service verification and validation protocols, plans, records, and product documentation.
• Lead complaint reviews, classification, trend monitoring, risk assessments, investigations, and corrective actions.
• Manage product safety activities, including Safety Risk Management Board tasks, Medical Device Reporting, field actions, and recalls.
• Analyze quality metrics and support continuous improvement projects, process development, and document control.

Requirements

• Bachelor’s degree in Engineering or a Science discipline.
• Strong analytical, organizational, multitasking, communication, presentation, and problem-solving skills.
• Ability to collaborate with cross-functional teams and communicate with senior management and employees at all levels.
• Experience with Microsoft Word, Excel, PowerPoint, and Project.
• Experience supporting AI-driven solutions, automation tools, or analytics platforms to improve business, quality, or operational processes.
• Ability to work in a hybrid office environment in Cranberry Township, Pennsylvania, and travel up to 25%.

Nice to have

• 1–2 years of professional experience.
• Experience in product development, maintenance, or process development.
• Experience in regulated environments, including ISO 9001, ISO 13485, or FDA-regulated settings.
• Experience with complex electromechanical systems and software products across the product lifecycle.

Culture & Benefits

• Comprehensive medical, dental, and vision plans for eligible US employees and dependents.
• Wellness and employee assistance programs, life insurance, and disability coverage.
• Retirement plans with matching and paid time off.
• Cross-functional collaboration with product management, engineering, and customer-facing organizations.