Senior Supplier Quality Engineer - Systems & Compliance

Becton, Dickinson and Company

Irvine (CA)

On-site

USD 106,000 - 169,000

Full time

3 days ago
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Benefits offered by this job

Health & Well-being
Retirement & Financial Well-being
Work-Life Balance & Family Support
Leave Programs

Job summary

Becton, Dickinson and Company is seeking a Supplier Quality Leader in Irvine to establish and enhance the Supplier Quality Management System. You will own supplier controls, auditing programs, risk management, and continuous improvement across sites and functions.

The role requires 5+ years in supplier quality or related quality functions within regulated manufacturing, with experience in eQMS, CAPA, and quality governance. On-site collaboration is emphasized in our BD values.

Qualifications

  • Bachelor's degree in engineering or related technical field required.
  • Minimum 5 years of Supplier Quality or related quality function experience in regulated manufacturing industries.
  • Experience with supplier controls, supplier auditing, risk management, change management, and CAPA systems.
  • Experience with electronic Quality Management Systems (eQMS) and data analytics preferred.

Responsibilities

  • Maintain and improve Supplier Quality and Purchasing Control procedures, records, and related documents.
  • Ensure regulatory and internal procedure compliance of supplier quality processes.
  • Lead harmonization of Supplier Quality processes across sites and functions.
  • Chair Supplier Quality Review Board governance activities and track actions.
  • Lead change control and improvement initiatives for supplier quality systems.
  • Maintain supplier qualification records and supplier files for audit readiness.
  • Manage Quality Agreement lifecycle activities and compliance tracking.
  • Monitor supplier certifications and renewal requirements for ongoing compliance.
  • Identify opportunities for automation and digitization of supplier quality processes.
  • Develop, maintain, and oversee the Supplier Audit Program and risk-based audit schedule.
  • Support supplier risk classification and audit prioritization.
  • Ensure audits are conducted per procedures and regulatory expectations.
  • Monitor findings, corrective actions, and verification activities.
  • Provide supplier quality documentation during internal, corporate, customer, and regulatory audits.
  • Maintain inspection readiness of supplier quality records and documentation.
  • Develop supplier quality metrics, dashboards, and management review inputs.
  • Analyze data to identify trends, risks, and improvement opportunities.
  • Lead continuous improvement projects using Lean, Six Sigma, or similar methods.
  • Drive preventive actions and systemic improvements to enhance efficiency and compliance.

Skills

Supplier quality systems
Auditing programs
Regulatory compliance
Risk management
CAPA systems
Lean Six Sigma
Documentation & writing
Stakeholder influence

Education

Bachelor's Degree in Engineering or related technical field

Tools

eQMS

Job description

Becton, Dickinson and Company is seeking a Supplier Quality Leader in Irvine to establish and enhance the Supplier Quality Management System. You will own supplier controls, auditing programs, risk management, and continuous improvement across sites and functions.

The role requires 5+ years in supplier quality or related quality functions within regulated manufacturing, with experience in eQMS, CAPA, and quality governance. On-site collaboration is emphasized in our BD values.

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