Senior Quality Engineer (Medical Devices)

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

Base compensation: $80,000–$115,000 per year.

Company

hirify.global develops regulated medical-device products and related technology solutions.

What you will do

• Lead defect management, engineering escalations, quality investigations, and corrective actions for product issues.
• Review and approve design and service verification and validation protocols for product changes and lifecycle processes.
• Coordinate cross-functional product change control and maintain Device Master Records for assigned product lines.
• Conduct post-production safety risk assessments and present product-specific risks to Safety Risk Management Boards.
• Manage Medical Device Reporting, field actions, recalls, internal audits, and CAPA activities.
• Develop quality metrics and lead continuous-improvement projects to reduce defects and improve customer satisfaction.

Requirements

• Bachelor’s degree in Engineering, Science, or a related discipline.
• At least five years of engineering, quality, or related technical professional experience.
• Experience in product development or maintenance, process development, and regulated environments such as ISO 9001, ISO 13485, or FDA QMSR.
• Advanced knowledge of QMS documentation and regulatory standards.
• Proficiency with quality investigation methods, statistical analysis, SPC, and Six Sigma.
• Understanding of SDLC, Jira, product change management, project management, problem-solving, communication, and leadership.

Nice to have

• Experience with complex electromechanical systems.
• Experience with cloud software and AI/ML.

Culture & Benefits

• Hybrid work in an office environment.
• 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.
• Travel may be required for up to 25% of working time.