Product Quality Engineer, II (Medical Devices)

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

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

Company

hirify.global develops products and services that require end-to-end quality support across design, development, release, and post-market activities.

What you will do

• Execute defect management and engineering escalation processes and support the product lifecycle process.
• Lead product change control, including documentation, cross-functional meetings, action tracking, queries, and metrics.
• Review and approve design and service verification and validation protocols, plans, and records.
• Maintain Device Master Records and ensure design outputs align with design inputs and approved protocols.
• Investigate field quality issues and potential safety concerns, support risk assessments, and participate in safety risk management activities.
• Manage Medical Device Reporting, field actions, recalls, complaint trend analysis, and quality improvement projects.

Requirements

• Bachelor’s degree in engineering, science, or a related discipline.
• At least 2 years of engineering, quality, or related technical professional experience.
• Strong analytical, organizational, project management, communication, presentation, multitasking, and problem-solving skills.
• Proficiency with Microsoft Word, Excel, PowerPoint, and Project.
• Experience with defect-tracking platforms such as Jira.
• Ability to work collaboratively, make decisions, meet tight deadlines, and communicate with employees and senior management.

Nice to have

• Experience in product development, maintenance, process development, and regulated environments.
• Knowledge of ISO 9001, ISO 13485, FDA QMSR, 21 CFR Part 11, IEC 62304, and software development lifecycle processes.
• Experience with complex electromechanical systems, cloud software, and AI/ML.

Culture & Benefits

• Cross-functional collaboration with product management, engineering, customer-facing organizations, and quality teams.
• 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.