Global Quality Senior Manager

Celestica; Kulai; On-site; MYR 120,000 - 160,000; Full time

Job summary

Celestica is seeking a Senior Quality Manager focused on New Product Introduction (NPI) in Kulai, Johor. The role requires leading Quality Management Systems to ensure both NPI objectives and customer requirements are consistently met. Ideal candidates will have over 15 years of experience in Quality Management with profund knowledge in ISO 13485 and a proven track record in managing product transitions from design to production. Join us to help shape quality processes at Celestica, where we value diversity and inclusion.

Qualifications

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

Responsibilities

• Lead the design and deployment of Quality Management Systems to ensure NPI objectives are met.
• Drive DFx reviews and oversight on validation strategies for seamless product transitions.
• Manage launch readiness assessments and Customer Satisfaction Surveys at the HealthTech sites.
• Ensure site-wide conformance to international regulations and customer certifications.
• Analyze data from customer scorecards and regulatory audits to identify gaps.

Skills

Expert-level knowledge of ISO 13485

Deep proficiency in defining critical quality business processes

Mastery of FMEA and 8D Methodology

Technical understanding of validation strategies

Ability to assess quality performance data

Education

Bachelor’s Degree or higher in Engineering or Quality Management

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

Job description

Senior Quality Manager - New Production Introduction (NPI) Focus

Req ID: 135519

Remote Position: No

Region: Asia

Country: Malaysia

State/Province: Johor

City: Senai

Responsibilities

• 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.

Knowledge, Skills & Competencies

• 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 (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).

Additional Information

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.

Equal Employment Opportunity Statement

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.