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 general 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/re

📌 Sr. Business Quality Manager (Tijuana)
🏢 WS Audiology
📍 Tijuana