Job Description:
The Supplier Quality Specialist will support supplier quality initiatives, manufacturing transfers, and new product implementation within a regulated manufacturing environment. This role partners with internal teams and suppliers to ensure product quality, process compliance, and successful execution of validation and supplier development activities. Responsibilities:
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.