Global Quality Manager

Celestica; Valencia; Presencial; EUR 120.000 - 180.000; Jornada completa

Descripción de la vacante

Celestica in Valencia, Spain, is looking for a Global Quality Manager focused on New Product Introduction (NPI). You will lead quality planning, DFx assessments, and compliance programs to ensure smooth transitions from design to mass production.

The role requires deep experience in QMS, ISO 13485, and multi-site leadership, with a track record of delivering launch readiness, regulatory alignment, and data-driven improvements.

Formación

• 15+ years of progressive experience in Quality Management.
• Proven track record in NPI, manufacturing scale-up, and global QMS deployment.
• Bachelor’s Degree or higher in Engineering, Quality Management or related technical field.
• Industry certifications preferred (ASQ, Six Sigma, ISO13485 Lead Auditor).

Responsabilidades

• Lead design and deployment of QMS processes to meet NPI objectives.
• Drive DFx reviews and validation readiness (IQ/OQ/PQ).
• Manage launch readiness assessments and customer satisfaction surveys.
• Ensure conformance to ISO 13485, ANSI/ESD and other regulatory requirements.
• Analyze quality data to identify gaps and implement action plans.
• Provide global QMS process ownership and training to sites.

Conocimientos

Quality Management

QMS

DFx

FMEA

8D Methodology

CCB

Regulatory compliance

Data analysis

Educación

Bachelor's degree in Engineering or related field

Herramientas

QMS software

Descripción del empleo

Global Quality Manager - New Product Introduction (NPI) Focus

• Quality Planning & Strategy: Lead the design and deployment of Quality Management Systems (QMS) processes and tools to ensure NPI objectives and customer requirements are met.
• DFx & Technical Readiness: Drive Design for Excellence (DFx) reviews and oversight on validation strategies (IQ,OQ,PQ) to ensure seamless product transitions from design to mass production.
• Launch Readiness: Manage launch readiness assessments, Monthly Operations Reviews, and Customer Satisfaction Surveys to ensure operational excellence at the HealthTech sites.
• Regulatory Oversight: Ensure site-wide conformance to international regulations and customer certifications (e.g., ISO 13485, ANSI/ESD).
• Performance Monitoring: Analyze data from customer scorecards, regulatory audits, and operational performance to identify gaps and communicate action plans to stakeholders.
• Global QMS process ownership: Develop and support key QMS processes to ensure regulatory compliance and mitigate operational risks.
• Process Deployment: Document and deploy global quality processes (Audit Compliance, Customer Feedback) in alignment with strategic corporate initiatives.
• Training & Capability Building: Educate sites on global procedures to build independent, high-functioning quality teams capable of maintaining long-term quality initiatives.
• Quality Frameworks: Expert-level knowledge of ISO 13485, 21 CFR 820 (QMSR) and ANSI/ISO/ESD standards.
• NPI Quality Planning: Deep proficiency in defining critical quality business processes, tools, and system applications required to meet site-level and customer-specific quality objectives.
• Advanced Quality Tools: Mastery of core quality methodologies, including FMEA (Failure Mode and Effects Analysis), 8D Methodology, Change Control Board (CCB) protocols, and Manufacturing Quality Standards (MQS).
• Validation & DFx: Technical understanding of validation strategies (IQ/OQ/PQ) and Design for Excellence (DFx) to ensure seamless transitions from design to mass production.
• Performance Analytics: Ability to assess quality performance data to establish metrics, targets, and improvement strategies (e.g., Monthly Operations Reviews, Quality Excursion Reporting).

15+ years of progressive experience in Quality Management, with a proven track record in NPI, manufacturing scale-up, and global QMS deployment.

• Bachelor’s Degree or higher in Engineering, Quality Management or a related technical field.
• Industry certifications preferred (ASQ, Six Sigma, ISO13485 Lead Auditor, etc).

This job description is not intended to be an exhaustive list of all duties and responsibilities of the position. Employees are held accountable for all duties of the job. Job duties and the % of time identified for any function are subject to change at any time.