Global Quality Senior Manager

Celestica Inc.; Kulai; On-site; MYR 250,000 - 380,000; Full time

Job summary

Celestica Inc. in Senai, Malaysia, is seeking a Global Quality Senior Manager to lead NPI quality planning, DFx oversight, and regulatory compliance across HealthTech sites.

You will drive QMS processes, value-driven quality improvements, and training to build high-functioning teams for design-to-mass production transitions.

Qualifications

• Lead design and deployment of QMS processes to meet customer requirements.
• Drive DFx reviews and validation strategies (IQ/OQ/PQ).
• Ensure regulatory conformance with ISO 13485 and ANSI/ESD.

Responsibilities

• Own global QMS processes and regulatory compliance.
• Document and deploy global quality processes per strategy.
• Educate sites on global procedures to build independent quality teams.
• Analyze data from audits and scorecards to identify gaps and action plans.
• Support NPIs and transitions from design to mass production.

Skills

Quality planning

DFx

NPI

Regulatory compliance

Performance analytics

QMS ownership

Training & capability

Education

Bachelor’s degree in Engineering or Quality Management

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

Tools

QMS software

Audit Compliance tools

Job description

Global Quality Senior Manager

Date: Jul 25, 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).

Notes

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.

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.

COMPANY OVERVIEW:
Celestica (NYSE, TSX: CLS) enables the world’s best brands. Through our recognized customer-centric approach, we partner with leading companies in Aerospace and Defense, Communications, Enterprise, HealthTech, Industrial, Capital Equipment and Energy to deliver solutions for their most complex challenges. As a leader in design, manufacturing, hardware platform and supply chain solutions, Celestica brings global expertise and insight at every stage of product development – from drawing board to full-scale production and after-market services for products from advanced medical devices, to highly engineered aviation systems, to next-generation hardware platform solutions for the Cloud.Headquartered in Toronto, with talented teams spanning 40+ locations in 13 countries across the Americas, Europe and Asia, we imagine, develop and deliver a better future with our customers.

Celestica would like to thank all applicants, however, only qualified applicants will be contacted.
Celestica does not accept unsolicited resumes from recruitment agencies or fee based recruitment services.

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