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.

• 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).

• 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.).