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.
- ssist 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.
