Senior Quality Engineer — MedTech Design & CAPA Expert

Becton Dickinson NA; Brea (CA); In loco; USD 106.000 - 169.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health & wellbeing

401(k) plan

Paid time off

Parental leave

Descrizione del lavoro

BD is seeking a Senior Quality Engineer in California to support new product development and maintenance for medical devices. You will apply advanced quality engineering methods to ensure compliance with design controls and regulatory requirements while leading CAPA investigations and process validation efforts.

The role emphasizes mentoring, cross-functional collaboration, and adherence to standards (21-CFR-820, ISO 13485, MDR/MDD, ISO 14971).

Competenze

• Bachelor's Degree with 7+ years in quality engineering for medical devices.
• Minimum 5 years supporting design assurance for medical devices.
• Extensive knowledge of regulatory standards (21-CFR-820, ISO 13485, MDR/MDD, ISO 14971, ISO 10993).
• ASQ cert desirable; Six Sigma design preferred.

Mansioni

• Provide support/mentoring for application of quality principles, theories and tools on design control and process control projects.
• Serve as a CAPA expert and drive root-cause investigations and corrective actions.
• Support internal and external quality system audits and management reviews.
• Mentor junior Associates and participate in cross-functional teams on multi-disciplinary projects.
• Act as site/functional SME and contribute to strategic, long-range planning.

Conoscenze

Quality engineering

CAPA expertise

Problem solving

Leadership

Communication

Formazione

Bachelor's Degree

Strumenti

ASQ certification desirable

Quality tools

Statistics

Descrizione del lavoro

BD is seeking a Senior Quality Engineer in California to support new product development and maintenance for medical devices. You will apply advanced quality engineering methods to ensure compliance with design controls and regulatory requirements while leading CAPA investigations and process validation efforts.

The role emphasizes mentoring, cross-functional collaboration, and adherence to standards (21-CFR-820, ISO 13485, MDR/MDD, ISO 14971).