Senior Supplier Quality Architect | Systems & Compliance Leader

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

Benefits offered by this job

Health & Well-being benefits

Retirement & Financial Well-being

Parental leave and educational support

Commuter benefits

Employee discounts

Job summary

BD is seeking a Senior Supplier Quality Engineer in Irvine, CA to lead the Supplier Quality System ownership and governance, ensure regulatory compliance, and drive continuous improvement across sites.

You will develop metrics, manage audits, and mentor teams while advancing automation in supplier quality processes. This role requires in-office presence and a strong background in medical device quality systems.

Qualifications

• Bachelor’s Degree in Engineering or related technical field.
• 5+ years in Supplier Quality, Quality Systems or related roles in regulated industries.
• Experience developing and maintaining Quality System procedures.
• Experience with supplier controls, supplier auditing, risk management, change management, and CAPA.
• Experience with electronic Quality Management Systems (eQMS) and data analytics preferred.

Responsibilities

• Own and improve Supplier Quality and Purchasing Control procedures and records.
• Ensure regulatory and company procedures compliance of supplier quality processes.
• Lead harmonization of supplier quality processes across sites.
• Lead Supplier Quality Review Board governance and action tracking.
• Drive changes and improvements to supplier quality procedures and systems.
• Maintain supplier qualification records and approved supplier files.
• Manage Quality Agreement lifecycle including renewal and compliance.
• Monitor supplier certifications and renewal requirements.
• Identify opportunities for automation and digitization in supplier quality.
• Develop and oversee Supplier Audit Program and risk-based schedule.
• Monitor audit findings and effectiveness verification.
• Provide supplier quality documentation during audits.
• Develop metrics and dashboards for supplier quality.
• Lead Lean Six Sigma or structured problem-solving projects.
• Provide training on supplier quality procedures.

Skills

Supplier Quality Systems

Regulatory compliance

CAPA systems

Auditing programs

Quality governance

Lean Six Sigma

Cross-functional leadership

Data analytics

Process validation

Documentation

Problem-solving

Communication skills

Stakeholder influence

Quality agreements

Education

Bachelor’s Degree in Engineering or related technical field

Tools

eQMS

Job description

BD is seeking a Senior Supplier Quality Engineer in Irvine, CA to lead the Supplier Quality System ownership and governance, ensure regulatory compliance, and drive continuous improvement across sites.

You will develop metrics, manage audits, and mentor teams while advancing automation in supplier quality processes. This role requires in-office presence and a strong background in medical device quality systems.