Sr Manager Global Quality - Healthtech, NPI and Electronics

Celestica; Apodaca; Vor Ort; MXN 1.200.000 - 2.000.000; Vollzeit

Zusammenfassung

Celestica in Mexico is seeking a Senior Quality Manager for New Production Introduction (NPI) focus. You will lead QMS design and deployment, driving DFx and validation strategies to ensure seamless design-to-mass production transitions.

The role oversees regulatory conformance, metrics, and continuous improvement across HealthTech sites. The ideal candidate has 15+ years in quality management with electronics manufacturing, ISO13485 and related standards, and a track record of global QMS

Qualifikationen

• Seasoned quality leader with 15+ years in QMS, NPI, and global deployments.
• Experience in electronic product manufacturing and healthtech environments preferred.
• Familiarity with ISO13485, FDA/IEC standards and regulatory audits.

Aufgaben

• Lead QMS design and deployment to meet NPI objectives and customer requirements.
• Drive DFx reviews and validation strategies from design to mass production.
• Manage launch readiness, OPS reviews, and customer satisfaction surveys.
• Ensure regulatory conformance and certifications across sites.
• Analyze scorecards and audits to identify gaps and drive corrective actions.
• Own global quality processes and risk mitigation across programs.
• Educate sites on procedures to sustain long-term quality initiative success.

Kenntnisse

Quality Planning

DFx

Launch Readiness

Regulatory Oversight

Quality Analytics

Global QMS

Process Deployment

Training & Capability

Quality Standards

NPI Quality

Validation & DFx

Electronics Manufacturing

Ausbildung

Bachelor's degree or higher in Engineering, Quality Management or related field

Tools

ISO 13485

21 CFR 820

ANSI/ISO/ESD

Jobbeschreibung

Senior Quality Manager - New Production Introduction (NPI) Focus

Detailed Description

• 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).
• Experience on manufacture of electronic products

Typical Experience

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

Typical Education

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