Supplier Quality Systems Leader - Medical Devices

Regulatory Jobs; Irvine (CA); On-site; USD 106,000 - 169,000; Full time

Benefits offered by this job

Health insurance

401(k) matching

Paid time off

Job summary

Becton, Dickinson, and Company (BD) in Irvine, CA seeks a Supplier Quality Leader to own and continuously improve the Supplier Quality Management System. You will drive governance, compliance, and cross-functional alignment across sites, leading change control and automation initiatives.

Candidates should have 5+ years in supplier quality within regulated industries, strong audit/CAPA experience, and proficiency with eQMS and data analytics tools. On-site role with a focus on quality governance.

Qualifications

• Bachelor's Degree in Engineering or related technical field.
• Minimum 5 years of experience in Supplier Quality, Quality Systems, or related quality functions in regulated industries.
• Experience developing, implementing, and maintaining Quality System procedures.
• Experience with supplier controls, supplier auditing, risk management, and CAPA systems.
• Experience with eQMS, reporting systems, and data analytics tools preferred.

Responsibilities

• Own and improve Supplier Quality Management System governance and procedures.
• Ensure regulatory and internal compliance across supplier processes.
• Lead harmonization of Supplier Quality processes across sites.
• Chair Supplier Quality Review Board governance and track actions.
• Lead change control for Supplier Quality procedures and systems.
• Drive improvements and automation in Supplier Quality workflows.
• Maintain supplier qualification records and approvals.
• Manage Quality Agreement lifecycle and supplier certifications.
• Monitor audit findings and effectiveness of corrective actions.
• Provide documentation during internal and external audits.

Skills

Supplier Quality

Quality Systems

Regulatory Compliance

Audit & CAPA

Risk Management

Lean Six Sigma

Data Analytics

Cross-functional Leadership

Documentation

Process Improvement

Education

Bachelor's Degree in Engineering or related technical field

Tools

eQMS

Reporting systems

Data analytics tools

Audit Programs

Job description

Becton, Dickinson, and Company (BD) in Irvine, CA seeks a Supplier Quality Leader to own and continuously improve the Supplier Quality Management System. You will drive governance, compliance, and cross-functional alignment across sites, leading change control and automation initiatives.

Candidates should have 5+ years in supplier quality within regulated industries, strong audit/CAPA experience, and proficiency with eQMS and data analytics tools. On-site role with a focus on quality governance.