Supplier Quality Specialist

• Collaborate with Engineering, Manufacturing, Procurement, and supplier partners to establish quality requirements and identify potential risks.
• Support supplier qualification, onboarding, and quality planning activities for new and existing products.
• Review and contribute to quality documentation including PFMEA, Control Plans, Process Flow Diagrams, MSA, SPC, and validation protocols.
• Coordinate supplier audits, performance evaluations, and continuous improvement initiatives.
• Investigate supplier-related quality concerns using CAPA, SCAR, Client, 8D, and root cause analysis methodologies.
• Support manufacturing transfer, design transfer, and engineering change activities while ensuring compliance with quality standards.
• Assist with process validation efforts, including IQ/OQ/PQ, equipment qualifications, validation builds, and production readiness.
• Partner with cross-functional teams to support regulatory compliance, quality objectives, and production launch activities.
• Contribute to New Product Introduction (NPI), supplier development, and sustaining engineering projects.

Requirements:

• Bachelor's degree in Engineering or a related technical discipline.
• 5+ years of experience in Supplier Quality, Manufacturing Quality, or Quality Engineering within a regulated industry.
• Strong understanding of APQP, PPAP (or SPPA), PFMEA, Control Plans, MSA, SPC, and process validation.
• Experience with supplier quality systems, CAPA, SCAR, Client, nonconformance investigations, and corrective/preventive actions.
• Familiarity with manufacturing transfers, product launches, engineering change management, or NPI activities.
• Working knowledge of ISO 13485, FDA Quality System Regulations, or comparable quality standards.
• Excellent analytical, communication, and cross-functional collaboration skills.

Preferred Qualifications:

• Experience supporting medical device manufacturing or other highly regulated industries.
• Prior experience with manufacturing transfers, supplier development, or design transfer programs.
• Knowledge of respiratory care, ventilator, CPAP, sleep therapy, or related healthcare products.
• Experience working with global suppliers and cross-functional engineering teams is a plus.