Quality Systems Lead, Medical Devices & ISO 13485

AirLife group; Glendale (AZ); Presencial; USD 32.000 - 45.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical

Dental

Vision

401(k)

Paid time off

Paid holidays

Bereavement leave

Employee assistance

Descripción de la vacante

AirLife is seeking a Quality Systems Lead to oversee FDA QSR/ISO 13485 compliance and audits. You will organize internal and external audits, maintain audit records, and drive improvements across the QMS.

This role requires strong documentation, communication, and cross-functional collaboration to ensure regulatory and customer requirements are met. The position focuses on maintaining and enhancing quality systems, conducting risk assessments, and mentoring teams to sustain compliance across

Formación

• ISO13485 Lead Auditor Certificate preferred.
• Minimum 5-7 years of Quality System experience in an FDA regulated and/or ISO certified facility.
• Occasional travel up to 25%.

Responsabilidades

• Develop and manage Internal Audit Plans.
• Coordinate internal audit activities and schedule.
• Lead external audits with notified bodies and customers.
• Maintain Audit Management Module in eQMS Grand Avenue and closure of internal audits.
• Own audit metrics, reporting, and trending.

Conocimientos

Auditing principles

Communication

Organizational skills

Problem solving

Computer skills

Educación

Bachelor/Associate degree

Herramientas

MS Word

MS Excel

PowerPoint

Database management

Statistical analysis

Descripción del empleo

AirLife is seeking a Quality Systems Lead to oversee FDA QSR/ISO 13485 compliance and audits. You will organize internal and external audits, maintain audit records, and drive improvements across the QMS.

This role requires strong documentation, communication, and cross-functional collaboration to ensure regulatory and customer requirements are met. The position focuses on maintaining and enhancing quality systems, conducting risk assessments, and mentoring teams to sustain compliance across