Global Quality Senior Manager (Medical Devices)

Celestica; Kulai; Hybrid; MYR 360,000 - 480,000; Full time

Job summary

Celestica in Johor Bahru, Malaysia, seeks a Global Quality Senior Manager (Medical Devices) to lead quality programs for new product introductions and manufacturing scale-up. You will drive regulatory compliance, advanced analytics, and cross-functional collaboration with senior leaders.

The role requires deep industry experience in medical devices, strong leadership, and travel to Singapore, China, Indonesia, and possibly Europe. Hybrid work arrangement may be discussed.

Qualifications

• Bachelor’s degree in Engineering or Quality Management.
• 15+ years in Quality Management with NPI and global QMS deployment.
• Experience in medical devices regulatory requirements.
• Willingness to travel up to 30–50%.

Responsibilities

• Lead global quality initiatives for medical devices, including NPI and manufacturing scale-up.
• Influence cross-functional teams and interact with General Managers and Vice Presidents.
• Drive improvement initiatives and performance analytics within QMS frameworks.
• Collaborate with customers and site teams to ensure regulatory compliance.

Skills

Leadership

Quality Management

Regulatory knowledge

NPI Quality

Stakeholder management

Education

Bachelor’s Degree or higher in Engineering/Quality Management

Job description

Global Quality Senior Manager (Medical Devices)

Performs tasks such as, but not limited to, the following:

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).

Requirements:

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

Industry certifications preferred (ASQ, Six Sigma, ISO13485 Lead Auditor, etc).

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

Other Info:

The role requires deep industry experience in medical devices, specifically 11 to 15+ years of progressive quality management experience with a record in New Product Introduction. The candidate must possess strong leadership, communication, and negotiation skills, as he / she will be working closely with customers and site teams. We prefer a candidate who has "grown up" in the industry to ensure they understand specific regulatory and Quality Management requirements.

The position is currently an individual contributor role with no direct reports, though he / she will utilize dotted-line reporting and influence to lead. The scope is strictly limited to the medical device segment, and we do not intend for the role to expand into other business segments in the near future. The position will require about up to 30% to 50% travelling to Singapore, Suzhou (China), Batam (indonesia) and potentially to our EU (Europena Union) sites as well.

The role is a true leadership position requiring the ability to influence cross-functional teams and interact with high-level stakeholders, including General Managers and Vice Presidents. Because the individual will need to navigate these relationships as an individual contributor, they must possess a high level of seniority and experience.

Work Location: Lot 1, Airport Logistics Park, Senai International Airport, 81250 Johor Bahru, Johor.
(Remote / Hybrid work arrangement can be further discussed)

Working Days / Hours: 8am to 5.30pm (Mondays to Fridays)

About us

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.