Quality Assurance Manager - Medical Devices (Onsite LA)

Yoh,-A-Day-; Redondo Beach (CA); Presencial; USD 129.000 - 145.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical, Dental, Vision

401(k)

Vacation

HSA

Life & Disability Insurance

EAP

Descripción de la vacante

Yoh, a Day & Zimmermann company, is seeking a Quality Assurance Manager to lead the QMS for a medical device client in the Los Angeles area. The role emphasizes ISO 13485, FDA QMSR, EU MDR, and MDSAP compliance, with responsibility for audits, CAPA, supplier quality, and continuous improvement.

The ideal candidate has hands-on medical device quality experience, strong leadership, and the ability to collaborate across Regulatory Affairs, Engineering, Operations, and executive leadership.

Formación

• Minimum 5–7 years of progressive Quality Assurance experience within medical device, pharmaceutical, biotechnology or another highly regulated industry.
• Strong working knowledge of ISO 13485 and FDA QMSR requirements.
• Experience leading CAPA, nonconformance management, root cause investigations, document control, change control, complaint handling, and internal auditing.
• Experience participating in and/or leading FDA, Notified Body, MDSAP, customer, supplier, and certification audits.
• Demonstrated ability to manage audit findings and regulatory observations through closure.

Responsabilidades

• Oversee the daily operations, maintenance, and continuous improvement of the Quality Management System (QMS).
• Lead internal, supplier, customer, Notified Body, MDSAP, and regulatory audits while maintaining inspection readiness.
• Develop and execute risk-based internal audit schedules and coordinate audit preparation, execution, responses, and CAPA.
• Lead CAPA program including investigations, root cause analysis, corrective actions, and effectiveness verification.
• Collaborate with Regulatory Affairs to support EU MDR compliance, post-market surveillance, risk management, and regulatory change assessments.
• Manage supplier quality activities including supplier qualification, audits, corrective actions, and performance evaluations.
• Establish Quality KPIs and report Quality System performance to management.

Conocimientos

Leadership

QMS ISO13485

Regulatory audits

CAPA investigations

Risk management

Document control

Internal auditing

Educación

Bachelor's degree in Engineering/Life Sciences/Quality

Herramientas

eQMS

Descripción del empleo

Yoh, a Day & Zimmermann company, is seeking a Quality Assurance Manager to lead the QMS for a medical device client in the Los Angeles area. The role emphasizes ISO 13485, FDA QMSR, EU MDR, and MDSAP compliance, with responsibility for audits, CAPA, supplier quality, and continuous improvement.

The ideal candidate has hands-on medical device quality experience, strong leadership, and the ability to collaborate across Regulatory Affairs, Engineering, Operations, and executive leadership.