Global Quality Leader – Medical Devices & Compliance

WS Audiology; Tijuana; Presencial; MXN 900.000 - 1.300.000; Jornada completa

Descripción de la vacante

WS Audiology in Mexico is seeking a Lead the Business Quality team to implement, maintain and continuously improve the Quality Management System (QMS) ensuring regulatory compliance and adherence to internal procedures.

The role provides leadership, guidance and technical support across functions, and collaborates with regional and global stakeholders to align local processes with corporate requirements and applicable regulations.

Formación

• ISO 13485 and MDSAP experience required.
• Advanced English written and spoken.
• Experience leading multidisciplinary teams in a regulated medical device environment.

Responsabilidades

• Lead and develop the Business Quality team and ensure the QMS is implemented, maintained and continuously improved.
• Provide guidance on quality, regulatory compliance and continuous improvement across functions.
• Oversee CAPA, audits, document control, training, KPI monitoring, Management Reviews, QIT, change management and supplier controls.

Conocimientos

Quality leadership

CAPA & RCA

Audit management

Document control

KPI monitoring

Change management

Supplier quality

Cross-functional

Regulatory compliance

English proficiency

Educación

Bachelor's degree in engineering or life sciences

Descripción del empleo

WS Audiology in Mexico is seeking a Lead the Business Quality team to implement, maintain and continuously improve the Quality Management System (QMS) ensuring regulatory compliance and adherence to internal procedures.

The role provides leadership, guidance and technical support across functions, and collaborates with regional and global stakeholders to align local processes with corporate requirements and applicable regulations.