Global Quality Leader – Medical Devices & NPI Excellence

Celestica Electronics (M) Sdn Bhd; Kulai; On-site; MYR 240,000 - 480,000; Full time

Job summary

Celestica Electronics (M) Sdn Bhd seeks a Global Quality Senior Manager for its medical devices segment. This individual will drive quality frameworks, participate in new product introductions, and lead cross-functional teams to ensure robust QMS across sites—and travel up to 50% to Singapore, Suzhou, Batam, and EU sites.

The role requires 15+ years in quality leadership, deep regulatory knowledge, and proven stakeholder influence at senior levels.

Qualifications

• 15+ years of progressive experience in Quality Management within medical devices.
• Proven track record in New Product Introduction, scale-up, and global QMS deployment.
• Strong leadership, communication, and stakeholder management skills.

Responsibilities

• Provide expert-level knowledge of ISO 13485, 21 CFR 820 and ANSI/ISO/ESD standards.
• Define critical quality processes, tools, and systems for site and customer objectives.
• Lead DFx, IQ/OQ/PQ validation, and quality performance analytics.

Skills

NPI management

Quality leadership

Regulatory compliance

Quality analytics

Cross-functional collaboration

Education

Bachelor's degree or higher in Engineering or Quality Management

Tools

ISO 13485

FMEA

QMS/ERP tools

Job description

Celestica Electronics (M) Sdn Bhd seeks a Global Quality Senior Manager for its medical devices segment. This individual will drive quality frameworks, participate in new product introductions, and lead cross-functional teams to ensure robust QMS across sites—and travel up to 50% to Singapore, Suzhou, Batam, and EU sites.

The role requires 15+ years in quality leadership, deep regulatory knowledge, and proven stakeholder influence at senior levels.