Global Quality Senior Manager - NPI

Celestica Inc.; Kulai; On-site; MYR 120,000 - 180,000; Full time

Job summary

Celestica Inc. is seeking a Global Quality Senior Manager to lead the Quality Management Systems with a focus on New Product Introduction (NPI). The role requires 15+ years of experience in quality management, ensuring compliance with international standards and leading quality teams.

The ideal candidate holds a Bachelor’s Degree in Engineering or related field, with strong expertise in ISO 13485 and DFx methodologies. Join us to drive operational excellence in a dynamic environment.

Qualifications

• 15+ years of progressive experience in Quality Management, particularly in NPI.
• Proven track record in manufacturing scale-up and global QMS deployment.
• Industry certifications preferred (ASQ, Six Sigma, ISO13485 Lead Auditor).

Responsibilities

• Lead the design and deployment of Quality Management Systems (QMS).
• Drive Design for Excellence (DFx) reviews and validation strategies.
• Manage launch readiness assessments and Customer Satisfaction Surveys.
• Ensure compliance with international regulations and customer certifications.
• Analyze data from customer scorecards and audits to identify gaps.

Skills

Quality Management Systems (QMS)

Design for Excellence (DFx)

FMEA (Failure Mode and Effects Analysis)

ISO 13485

Analytical skills

Education

Bachelor’s Degree or higher in Engineering, Quality Management or a related technical field

Tools

8D Methodology

Change Control Board (CCB) protocols

Job description

Global Quality Senior Manager - NPI

Date: May 28, 2026

Location: Senai, 01, MY

Req ID: 135519
Remote Position: No
Region: Asia
Country: Malaysia
State/Province: Johor
City: Senai

Summary

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).

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).

Celestica is an equal opportunity employer. All qualified applicants will receive consideration for employment and will not be discriminated against on any protected status (including race, religion, national origin, gender, sexual orientation, age, marital status, veteran or disability status or other characteristics protected by law).
At Celestica we are committed to fostering an inclusive, accessible environment, where all employees and customers feel valued, respected and supported. Special arrangements can be made for candidates who need it throughout the hiring process. Please indicate your needs and we will work with you to meet them.