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Sr Engr, Supplier Quality

BD
4 hours ago
On-site
Laguna Canyon, United States
$105,500 - $168,800 USD yearly
Indeed

Now We are the people who give possibilities purpose BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. Job Description Position Purpose Apply advanced knowledge of quality systems, supplier controls, auditing, risk management, and continuous improvement methodologies to establish, maintain, and improve the Supplier Quality Management System. Ensure supplier quality processes remain compliant with applicable regulatory requirements, industry standards, and company procedures while driving system effectiveness, governance, and operational excellence. Key Responsibilities Supplier Quality Management System Ownership & Governance Own, maintain, and continuously improve Supplier Quality and Purchasing Control procedures, work instructions, forms, templates, and associated records. Ensure Supplier Quality processes remain compliant with applicable regulatory requirements, internal procedures, and Quality System requirements. Lead harmonization and standardization of Supplier Quality processes across sites and business functions. Chair and facilitate Supplier Quality Review Board governance activities and action tracking. Lead change control activities related to Supplier Quality procedures and systems. Drive implementation and effectiveness monitoring of Supplier Quality process improvements. Maintain supplier qualification records, supplier compliance documentation, and approved supplier files. Manage Quality Agreement lifecycle activities, including execution, monitoring, renewal, and compliance tracking. Monitor supplier certifications and renewal requirements to ensure ongoing compliance. Ensure supplier quality records remain complete, accurate, traceable, and inspection ready. Identify opportunities for automation, digitization, and workflow optimization within Supplier Quality processes. Supplier Audit Program & Compliance Management Develop, maintain, and oversee the Supplier Audit Program and risk-based audit schedule. Support supplier risk classification and audit prioritization strategies. Ensure supplier audits are executed in accordance with established procedures and regulatory expectations. Monitor audit findings, corrective actions, and effectiveness verification activities. Provide supplier quality documentation and objective evidence during internal, corporate, customer, and regulatory audits. Maintain ongoing inspection readiness of Supplier Quality records and supporting documentation. Performance Monitoring & Continuous Improvement Develop and maintain Supplier Quality metrics, dashboards, compliance indicators, and management review reports. Analyze supplier quality and system performance data to identify trends, risks, and improvement opportunities. Support Quality Data Reviews and Management Review processes. Develop meaningful KPIs to monitor Supplier Quality System effectiveness. Lead continuous improvement projects utilizing Lean, Six Sigma, or structured problem-solving methodologies. Drive preventive actions and systemic improvements to improve process efficiency and compliance. Supplier Quality Systems Leadership Serve as the Supplier Quality Systems subject matter expert for the organization. Provide guidance and training on Supplier Quality procedures, systems, and compliance requirements. Partner with Supplier Quality Engineering, Procurement, Manufacturing, Operations, Regulatory Affairs, and Quality Systems teams to ensure alignment and effective implementation of Supplier Quality processes. Support strategic initiatives involving supplier governance, business process improvement, and quality system transformation. Additional Resp…

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