Supplier Quality Engineer

Job Summary: Provide support to the Supplier Quality organization dedicated to the oversight of components, materials, and services. Serve as a technical resource across the organization to ensure suppliers meet all quality, regulatory, and business requirements. Roles & Responsibilities: Conduct technical reviews of suppliers to assess their capability to manufacture materials and components. Oversee, assess, and monitor supplier manufacturing processes, quality control practices, corrective actions, continuous improvement activities, and First Article Inspections (FAI). Define and approve PPAP (Production Part Approval Process) requirements for new and revised purchased parts. Collaborate with suppliers, Research & Development, and Design Assurance teams to ensure products meet fit, form, function, reliability, and quality requirements. Issue, manage, and follow up on supplier quality events including SCARs, SACAs, and NCEs while monitoring workflow compliance with established KPIs. Partner with suppliers to perform root cause investigations, problem solving, metrology assessments, and statistical analysis to prevent recurring failures. Work with Post Market Surveillance, Quality Engineering, Manufacturing Engineering, R&D, and other cross-functional teams to resolve supplier-related complaints and quality issues. Manage supplier-related nonconformities, containment actions, material disposition activities, and supplier sample returns as required. Maintain complete and accurate supplier quality records. Generate supplier performance metrics and reports to support stakeholder decision-making. Qualify, coordinate, and execute activities associated with onboarding and implementation of new suppliers. Utilize problem-solving tools such as SPC, TQM, and statistical sampling methodologies to optimize processes. Ensure compliance with Medical Device Regulations, cGMP, CFR 820, ISO 13485, ISO 14971, ISO 9001, and applicable global regulatory requirements. Support risk management activities, validation efforts (IQ, OQ, PQ), CAPA investigations, project management initiatives, and measurement system analysis (GR&R, AAA). Education & Experience: Bachelor's degree in an Engineering field from an accredited university. Minimum 8 years of professional experience. Medical Device industry experience required. ISO 13485 Lead Auditor certification required. Strong knowledge of Medical Device Regulations, cGMP, CFR 820, ISO 13485, ISO 14971, and ISO 9001. Experience with risk management, CAPA, IQ/OQ/PQ validations, measurement system analysis (GR&R, AAA), SPC, statistical sampling, and PPAP. Knowledge of project management techniques and global regulatory requirements (FDA, Canada, Brazil, Japan, etc.).