Global NPI Quality Leader

Celestica Inc.; Monterrey; Híbrido; MXN 900.000 - 1.300.000; Jornada completa

Descripción de la vacante

Celestica Inc. seeks a Global Quality Senior Manager focused on New Production Introduction (NPI) to lead quality planning and DFx readiness across HealthTech sites. You will drive validation strategy, manage launch readiness, and ensure regulatory conformance with ISO 13485 and ANSI/ESD.

You will also analyze scorecards, audits, and performance data to close gaps, while deploying global QMS processes and coaching teams to sustain long-term quality excellence.

Formación

• Bachelor’s degree in Engineering or related technical field.
• 15+ years in Quality Management with NPI and global QMS deployment.
• Experience with ISO 13485 and regulatory standards (e.g., 21 CFR 820).

Responsabilidades

• Lead quality planning and strategy to meet NPI objectives and customer requirements.
• Drive DFx reviews and validation oversight (IQ/OQ/PQ) for seamless transitions to mass production.
• Manage launch readiness assessments, monthly reviews, and customer satisfaction surveys.
• Ensure site-wide regulatory conformance and certifications (ISO 13485, ANSI/ESD).
• Analyze quality data from audits and scorecards to identify gaps and drive actions.
• Own global QMS processes and deploy them across sites per corporate initiatives.
• Document and deploy global quality processes (Audit Compliance, Customer Feedback).
• Educate sites on procedures to build independent, high-functioning quality teams.
• Leverage tools and methodologies (FMEA, 8D, CCB) to improve quality performance.
• Understand validation strategies (IQ/OQ/PQ) and DFx to support product transitions.

Conocimientos

Quality Mgmt

NPI

DFx

Regulatory Compliance

Data Analytics

Educación

Bachelor's Degree in Engineering or related field

Industry certifications preferred (ASQ, Six Sigma, ISO13485 Lead Auditor)

Herramientas

QMS tools

Descripción del empleo

Celestica Inc. seeks a Global Quality Senior Manager focused on New Production Introduction (NPI) to lead quality planning and DFx readiness across HealthTech sites. You will drive validation strategy, manage launch readiness, and ensure regulatory conformance with ISO 13485 and ANSI/ESD.

You will also analyze scorecards, audits, and performance data to close gaps, while deploying global QMS processes and coaching teams to sustain long-term quality excellence.