Sr Engr, Supplier Quality

Becton Dickinson; Irvine (CA); On-site; USD 120,000 - 170,000; Full time

Job summary

BD in Irvine seeks a Supplier Quality leader to own the Supplier Quality Management System, driving compliance and continual improvement across global sites. You will lead audits, supplier controls, risk management, and CAPA programs, collaborating with Procurement, Manufacturing, Regulatory Affairs, and Quality Systems to ensure device safety and quality.

The role emphasizes governance, change control, data analytics, and automation opportunities to raise process efficiency and supplier

Qualifications

• Minimum 5 years of experience in Supplier Quality, Quality Systems, Quality Engineering, Compliance, or related quality functions within regulated manufacturing industries.
• Experience developing, implementing, and maintaining Quality System procedures and processes.
• Experience with supplier controls, supplier auditing, risk management, change management, and CAPA systems.

Responsibilities

• 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.

Skills

Quality systems

Supplier controls

Auditing

Risk management

CAPA

Education

Bachelor's Degree in Engineering

Tools

eQMS

Data analytics tools

Job description

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 Responsibilities

• Support enterprise-wide Quality System initiatives as assigned.
• Perform other duties as required to support business objectives.

Qualifications

Education

• Bachelor's Degree in Engineering or related technical field.

Experience

• Minimum 5 years of experience in Supplier Quality, Quality Systems, Quality Engineering, Compliance, or related quality functions within the medical device, pharmaceutical, biotechnology, or regulated manufacturing industries.
• Experience developing, implementing, and maintaining Quality System procedures and processes.
• Experience with supplier controls, supplier auditing, risk management, change management, and CAPA systems.
• Experience working with electronic Quality Management Systems (eQMS), reporting systems, and data analytics tools preferred.

Required Skills

• Demonstrated knowledge of Supplier Quality Systems, supplier controls, auditing programs, purchasing controls, quality agreements, and supplier governance processes.
• Working knowledge of applicable regulations