Senior Supplier Quality Engineer (Medical Devices)

Location: Hybrid role based at hirify.global's US manufacturing facility in Cranberry Township, Pennsylvania; listed location is Warrendale, PA, United States. Travel of up to 30%, including international travel, may be required.

Base compensation: $95,000–$117,433 per year.

Company

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

What you will do

• Lead supplier design-for-manufacturability discussions and manage supplier qualifications for new product introductions and sustaining engineering changes.
• Develop supplier IQ/OQ/PQ protocols and final reports, ensuring statistically valid sampling sizes.
• Guide suppliers in establishing controlled manufacturing processes using control plans, PFMEA, and statistical process control.
• 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.
• Analyze supplier performance data from ERP and PLM systems, create metrics and presentations, and implement supplier-performance improvement strategies.

Requirements

• At least five years of quality or manufacturing experience.
• BS degree in engineering or technical science.
• Experience in ISO 13485 or FDA-regulated medical-device environments.
• Working knowledge of auditing methodologies for ISO 9001 and ISO 13485.
• Knowledge of quality tools including Pareto analysis, fishbone diagrams, FMEA, SCAR, CAPA, and statistical process control.
• Ability to interpret engineering drawings and specifications, communicate with suppliers and stakeholders, manage projects, and deliver work under tight deadlines.

Nice to have

• ISO 13485 and ISO 9001 Certified Lead Auditor credentials from an accredited body.
• Experience with ISO 9001, ISO 14001, or 21 CFR 820.
• Six Sigma Green Belt or higher.
• Knowledge of sheet metal forming and injection molding.

Culture & Benefits

• Office-based hybrid work environment with collaboration across the global factory network.
• Opportunity to lead continual improvement of supplier quality processes and corporate quality projects.
• Medical, dental, and vision plans for eligible US employees and dependents.
• Wellness and employee assistance programs, life insurance, disability coverage, retirement plans with matching, and paid time off.
• Work includes international supplier engagement and may involve up to 30% travel.