Senior Design Quality Engineer (Advanced Technology Solutions)

Celestica; George Town; On-site; MYR 60,000 - 110,000; Full time

Job summary

Celestica is seeking a Senior Design Quality Engineer (Advanced Technology Solutions) in Malaysia to own and continuously improve the site quality management system. You will ensure engineering and project processes meet customer requirements, Celestica procedures, and applicable standards.

You will coordinate audits, drive CAPA/RCCA, monitor KPIs, and partner with design, reliability, and regulatory teams to address product safety, labeling, and documentation before release.

Qualifications

• Bachelor’s degree in engineering, quality, science, regulatory affairs, or a related discipline.
• Typically 5–8 years of experience in quality engineering, QA, or regulatory compliance.
• Experience implementing or maintaining a QMS and supporting audits.
• Ability to interpret customer requirements and convert them into actionable controls.
• Strong written and verbal communication skills for cross-functional teams.

Responsibilities

• Own and maintain the site-level QMS framework and related documents.
• Act as site Quality Representative for QMS implementation and audits.
• Ensure processes are deployed with objective evidence in records.
• Plan and support internal, customer, certification-body, and regulatory audits.
• Monitor QMS performance and provide trend analysis to site leadership.
• Lead CAPA, RCCA, and continual-improvement activities.
• Coordinate quality and compliance reviews across engineering and other teams.
• Maintain release evidence and regulatory documentation for projects.

Skills

Quality engineering

Regulatory compliance

Risk management

Root-cause analysis

Documentation control

Audit preparation

Cross-functional collaboration

Project management

Communication skills

Education

Bachelor’s degree in engineering, quality, science, regulatory affairs, or a related discipline

Tools

8D/RCCA

CAPA

FMEA

Document control systems

Quality records management

Job description

Senior Design Quality Engineer (Advanced Technology Solutions)

We are seeking a talented and motivated individual to join our dynamic and growing organization to deliver products that leave a positive impact to the world.

TheQuality Engineer is responsible for owning and continuously improving site-level Quality Management System (QMS) activities. This role ensures that engineering and project execution processes comply with applicable customer requirements, Celestica procedures, industry standards, and statutory and regulatory requirements.

The position also supports product and project teams in establishing compliance evidence for market entry, including requirements review, risk-based planning, technical documentation, verification evidence, conformity assessment, and coordination with internal and external regulatory stakeholders.

Our organization is built on a culture that prioritizes continuous learning and people development. The Quality Engineer will have the opportunity to grow within this environment, leveraging an extensive global network of expertise.

Key Responsibilities

Own and maintain the site-level QMS framework, including local procedures, work instructions, forms, records, process interfaces, and quality objectives.

Act as the site Quality Representative and primary point of contact for QMS implementation, compliance monitoring, and quality-system questions.

Ensure site processes are effectively deployed, understood, followed, and supported by objective evidence in the approved document and record-control systems.

Maintain site-level quality documentation, including document revision control, controlled records, training matrices, quality logs, organization charts, and management-review inputs.

Plan, coordinate, and support internal, customer, certification-body, and regulatory audits; track findings through containment, root-cause analysis, corrective action, effectiveness verification, and closure.

Monitor QMS performance, quality objectives, key performance indicators, customer feedback, complaints, nonconformances, and recurring issues; provide trend analysis and improvement recommendations to site leadership.

Lead or coordinate nonconformance, corrective and preventive action (CAPA), root-cause corrective action (RCCA), and continual-improvement activities. *Ensure nonconforming materials, deliverables, processes, and records are identified, documented, contained, evaluated, and dispositioned in accordance with applicable procedures.

Coordinate quality and compliance reviews across engineering, project management, supply chain, customer engineering, facilities, and other functional teams.

Define and maintain quality plans, inspection or review criteria, compliance matrices, traceability records, and release evidence for applicable projects.

Review customer, contractual, statutory, regulatory, and industry-standard requirements and translate them into clear project and site actions.

Support market-entry readiness by identifying applicable product regulations and standards, defining evidence requirements, coordinating testing and verification activities, and tracking compliance gaps to closure.

Partner with design, systems, reliability, test, and regulatory teams to ensure product risks, safety requirements, labeling or documentation needs, and conformity requirements are addressed before release or market submission.

Coordinate preparation and review of technical files, declarations, certificates, test reports, risk records, and other compliance evidence required for customer acceptance or market entry, as applicable to the project.

Maintain awareness of changes to applicable standards and regulations and assess their potential impact on the QMS, projects, deliverables, and market-access plans.

Provide quality and regulatory guidance during requirements review, design planning, design reviews, verification and validation, design transfer, engineering change control, and project closeout.

Deliver QMS and compliance awareness training; verify that personnel are trained and competent for assigned quality-impacting activities.

Promote a right-first-time, risk-based, customer-focused, and continual-improvement culture across the site.

Required Qualifications

Bachelor’s degree in engineering, quality, science, regulatory affairs, or a related discipline.

Typically, 5-8 years of experience in quality engineering, quality assurance, design quality, regulatory compliance, or a related role in an engineering, electronics, medical-device, aerospace, industrial, or similarly regulated environment.

Practical experience implementing or maintaining a QMS and supporting internal or external audits.

Working knowledge of quality tools such as 8D/RCCA, CAPA, risk management, FMEA, root-cause analysis etc.

Experience with document control, quality records, training records, change control, nonconformance management, and audit-finding closure.

Ability to interpret customer requirements, contractual obligations, statutory requirements, regulations, and industry standards and convert them into actionable controls.

Strong written and verbal communication skills, with the ability to influence cross-functional teams and communicate with customers, auditors, certification bodies, and regulatory stakeholders.

Strong analytical, organizational, problem-solving, and project-management skills.

Preferred Qualifications

Experience with one or more of ISO 9001, ISO 13485, AS9100, IEC 60601, IEC 62304 or other relevant standards, depending on the supported market and product.

Experience supporting product compliance, conformity assessment, certification, regulatory submissions, or market-entry activities.

Internal auditor or lead auditor experience

Knowledge of design controls, requirements traceability, verification and validation, product safety, configuration management, and engineering change management.

Experience working with global teams, suppliers, customers, or third-party test laboratories.

Quality and compliance ownership

Regulatory and standards interpretation

Risk-based thinking

Audit readiness and evidence-based execution

Creative problem solving and structured corrective action

Cross-functional collaboration and stakeholder management

Clear communication and technical writing

Data analysis and performance monitoring

Attention to detail and disciplined follow-through