Ingeniero Sr de Calidad de Proveedores

Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.

Supplier Quality is responsible for managing external suppliers throughout the product lifecycle, including evaluating and qualifying suppliers, monitoring supplier performance, auditing supplier's quality management system to applicable regulations and quality standards, providing metrics, and addressing quality and regulatory issues.

Responsibilities

• Adhere to Good Manufacturing Principles (GMPs) based Quality Management Systems requirements for medical devices and medicinal products
• Lead supplier qualification, evaluation, and monitoring activities to ensure ongoing compliance with quality and regulatory requirements.
• Partner with suppliers to improve quality performance, address nonconformances, and implement sustainable corrective and preventive actions.
• Identify and lead implementation of preventive and corrective actions via CAPAs, audits, NCRs, and complaint handling systems.
• Review and approve supplier quality documentation, change notifications, and quality agreements as applicable.
• Lead implementation of Supplier Change Requests.
• Plan, conduct, and support supplier audits, assessments, and follow-up activities.
• Investigate supplier-related quality issues, identify root causes, and drive timely resolution of complex problems.
• Key contributor on NPD (New Product Development) projects, ensuring rigorous performance and APQP deliverables (CTQ, PFMEA, control plan, GRR, FAI, IQ/OQ/PQ, PPA, etc.), in collaboration with Procurement, Manufacturing and R&D.
• Collaborate with Engineering, Operations, Regulatory Affairs, and other cross-functional teams to support product and process quality objectives.
• Ensure supplier quality systems adhere to all applicable regulations and standards
• Analyze supplier quality trends and metrics to identify risks and improvement opportunities.
• Ability to lead and influence cross-functional teams to drive reduction in patient safety risk and greater levels of regulatory compliance
• Apply experience and knowledge of MDD (Medical Device Directive),
• Participate in continuous improvement projects focused on quality system effectiveness and supplier performance.
• Support supplier development initiatives that strengthen product quality, compliance, and supply continuity. EU-MDR (Medical Device Regulations), ISO 13485 (Quality Management Systems), Pharmaceutical guidelines, FDA, cGMP, and Risk Management (ISO 14971) to instill a culture dedicated to ensuring patient safety and sustained regulatory compliance

• 4-8 years of experience, preferred
• Bachelor's degree in related field, or equivalent work experience, preferred
• Advanced English (speaking and reading)

• Knowledge of supplier qualification processes, audits, root cause analysis, CAPA systems, and quality management principles.
• Experience working in regulated environments is preferred.
• Strong analytical, communication, and stakeholder management skills.
• Ability to manage multiple priorities while maintaining attention to detail and quality standards.
• Advanced English communication skills.

Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.