Sr. Business Quality Manager

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

Lead the Business Quality team and ensure the implementation, maintenance and continuous improvement of the Quality Management System (QMS), ensuring compliance with applicable regulatory requirements, quality standards and internal procedures.

The position provides leadership, guidance and technical support to different functional areas on quality, regulatory compliance and continuous improvement matters. The role also collaborates with regional and global stakeholders to ensure alignment between local processes, corporate requirements and applicable regulations.

The position is responsible for activities related to CAPA, internal and external audits, document control, training, KPI monitoring, Management Review, Quality Improvement Team (QIT), change management and supplier controls.

• Lead and develop the Business Quality team, ensuring the achievement of departmental objectives and responsibilities.
• Ensure compliance with the Quality Management System (QMS) and applicable regulatory requirements.
• Oversee CAPA and Root Cause Analysis (RCA) processes, internal and external audits, and timely closure of findings.
• Coordinate document control, change management, employee training, and compliance with Good Documentation Practices (GDP).
• Monitor quality KPIs, analyze trends, and prepare reports to support decision-making.
• Organize and facilitate Management Reviews and Quality Improvement Team (QIT) meetings.
• Provide quality guidance and support to different functional areas across the organization.
• Oversee supplier quality controls and incoming inspection processes.
• Collaborate with regional and global teams on quality-related projects and regulatory compliance activities.
• Promote a culture of quality, regulatory compliance, and continuous improvement throughout the organization.

• 5–8 years of experience working with ISO 13485 and MDSAP within the medical device manufacturing industry.
• 3–5 years of experience leading teams and with supervisory/reporting responsibilities.
• At least 5 years of experience working within multidisciplinary teams.
• Experience in local and global project management.
• Experience working within regulated environments and Quality Management Systems.
• General understanding of the Hearing Aids / Hearing Devices industry.
• Experience working with international teams, including colleagues from the United States, Europe and Asia.
• Advanced English, written and spoken.
• Ability to effectively communicate and collaborate with international teams and stakeholders.