Supplier Quality Engineer II (Medical Devices)

Location: Hybrid, based at the hirify.global manufacturing facility in Warrendale, Pennsylvania, United States. International travel of up to 30% may be required.

Base compensation: $65,000–$93,000 per year.

Company

hirify.global develops and manufactures solutions for medication management and healthcare environments.

What you will do

• Analyze and trend supplier performance data from ERP and PLM systems.
• Create supplier quality metrics, reports, presentations, and management review materials.
• Lead SCAR and CAPA activities for supplier product and process quality issues, including effectiveness verification.
• Plan and execute supplier audits against hirify.global quality standards and regulatory requirements.
• Support new product introduction, component qualification, and supplier corrective actions across the global factory network.
• Review IQ/OQ/PQ protocols and reports and help suppliers maintain Control Plans, PFMEA, and PPAP documentation.

Requirements

• At least 3 years of quality or manufacturing experience.
• Bachelor’s degree in Engineering or Technical Science.
• Working knowledge of auditing methodologies for ISO 9001 or ISO 13485.
• Knowledge of Pareto analysis, fishbone diagrams, FMEA, PPAP, CAPA, engineering drawings, and manufacturing processes.
• Strong communication, presentation, analytical, organizational, project management, and multitasking skills.
• Proficiency with Microsoft Word, Excel, PowerPoint, and Project.

Nice to have

• ISO 13485 or FDA-regulated medical device experience.
• Experience with ISO 9001, ISO 14001, or 21 CFR 820.
• Certified Lead Auditor qualification.

Culture & Benefits

• Fast-paced environment emphasizing collaboration, initiative, diplomacy, and continuous improvement.
• Medical, dental, and vision plans for eligible US employees and dependents.
• Wellness and employee assistance programs, life insurance, disability coverage, and retirement plans with matching.
• Paid time off.
• Drug screening is required.