Senior Supplier Quality Engineer NPD & Compliance

Regulatory Jobs; Irvine (CA); In loco; USD 130.000 - 207.000; Tempo pieno

Descrizione del lavoro

BD is a global medical technology leader seeking a senior supplier quality professional to lead supplier qualification, audit, and quality systems for NPD and lifecycle programs. You will drive CAPAs, supplier development, and risk-based validation while partnering with manufacturing sites and global suppliers.

The role emphasizes leadership in CAPAs, NCRs, audits, change management, and regulatory compliance with FDA/ISO standards, including ISO 13485 and ISO 14971.

Competenze

• Bachelor’s degree in engineering or scientific field with 6 years’ experience (industry or academia).
• Master’s degree or equivalent with 5 years’ experience (industry or academia).
• Ph.D. or equivalent with 2 years’ experience (industry or academia).

Mansioni

• Lead supplier qualification, quality management, and development for NPD and lifecycle programs.
• Define qualification strategies for components, devices, and materials balancing R&D and manufacturability.
• Improve supplier sites viaRobust quality systems and process controls to enable operational excellence.

Conoscenze

Supplier quality leadership

Cross-functional collaboration

Regulatory compliance knowledge

Lean Six Sigma

Formazione

Bachelor’s degree in engineering or Scientific field

Master's degree or equivalent in Engineering or Scientific field

Ph.D. or equivalent in Engineering or Scientific field

Strumenti

ASQ Biomedical Auditor

Six Sigma Black Belt

Descrizione del lavoro

BD is a global medical technology leader seeking a senior supplier quality professional to lead supplier qualification, audit, and quality systems for NPD and lifecycle programs. You will drive CAPAs, supplier development, and risk-based validation while partnering with manufacturing sites and global suppliers.

The role emphasizes leadership in CAPAs, NCRs, audits, change management, and regulatory compliance with FDA/ISO standards, including ISO 13485 and ISO 14971.