Assistant Quality Manager / Quality Section Manager

jabil; Singapore; On-site; SGD 120,000 - 180,000; Full time

Job summary

Jabil in Singapore seeks an Assistant Quality Manager / Quality Section Manager to lead Quality Engineering and Quality Assurance, ensuring ISO 13485, FDA QMSR, and customer requirements for healthcare devices. You will drive quality strategy and coach teams across Manufacturing, Engineering and Regulatory Affairs.

The role covers NPI, supplier and customer quality, CAPA and risk management, process validation, and continuous improvement.

Qualifications

• Experience implementing ISO 13485 compliant QMS.
• Knowledge of FDA 21 CFR Part 820 / QMSR.
• Knowledge of MDSAP and customer-specific requirements.
• Experience leading CAPA and risk management.
• Experience in a medical device manufacturing environment.

Responsibilities

• Coach and develop Quality Engineers, Technicians, and Inspectors.
• Drive KPIs and quality objectives aligned with site strategy.
• Lead QMS maintenance and continuous improvement.
• Guide Quality Engineering support for manufacturing and NPI.
• Lead investigations for CAPA, nonconformances, and customer complaints.
• Interface with healthcare customers and audits.

Skills

Leadership

People Management

Cross-functional Collaboration

Regulatory Compliance

Quality Engineering

Quality Assurance

Job description

At Jabil (NYSE: JBL), we are proud to be a trusted partner for the world's top brands, offering comprehensive engineering, supply chain, and manufacturing solutions. With 60 years of experience across industries and a vast network of over 100 sites worldwide, Jabil combines global reach with local expertise to deliver both scalable and customized solutions. Our commitment extends beyond business success as we strive to build sustainable processes that minimize environmental impact and foster vibrant and diverse communities around the globe.

Assistant Quality Manager / Quality Section Manager (Healthcare)

JOB SUMMARY

Assist Quality Manager to manage the Quality Engineering and Quality Assurance functions to ensure compliance with applicable regulatory requirements, Quality Management System (QMS) standards, customer requirements, and company objectives.Provide strategic and technical leadership to support manufacturing operations, New Product Introduction (NPI), supplier quality, customer quality, and continuous improvement initiatives for healthcare and non healthcare finished medical device.Collaborate closely with cross-functional teams and healthcare customers to drive product quality, operational excellence, and regulatory compliance within a medical device manufacturing environment.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Leadership & People Management

• Assist Quality Manager on coach, mentor and develop Quality Engineers, Quality Technicians, and Inspectors to achieve quality and business objectives.
• Drive departmental goals, KPIs and performance expectations aligned with site quality strategy.
• Identify training needs and ensure compliance with quality and regulatory training requirements.
• Foster a culture of behavior based quality, accountability, continuous improvement and customer focus.
• Lead the quality organization during customer escalations, quality crises, product containment and recovery activities.
• Promote collaboration across Manufacturing, Engineering, Supply Chain, Regulatory Affairs, and Operations teams.

Quality Management System (QMS)

• Ensure effective implementation, maintenance and continuous improvement of the Quality Management System in compliance with: ISO 13485
• FDA 21 CFR Part 820 / QMSR
• MDSAP
• Customer-specific requirements
• Monitor QMS metrics and drive system improvements.
• Review and approve quality procedures, work instructions, specifications, forms and records.
• Support Management Review and Quality Review Board activities.

Quality & Technical Management

• Lead Quality Engineering support for manufacturing operations and NPI projects.
• Develop and maintain Quality Plans, Control Plans and APQP deliverables.
• Drive process validation and qualification activities including IQ, OQ and PQ.
• Lead Process FMEA, Risk Assessment and Control Plan development.
• Support quotation and transfer activities through quality planning and risk evaluation.
• Establish inspection methodologies, acceptance criteria, sampling plans and measurement systems.
• Review and improve inspection processes, gauges, fixtures and quality controls.
• Analyze quality performance data and identify opportunities for process improvement.
• Lead implementation of SPC, process capability studies and quality monitoring systems.
• Partner with Engineering and Operations to improve yield, reduce defects and lower Cost of Poor Quality (COPQ).

CAPA, Nonconformance & Complaint Management

• Lead investigations related to: Nonconforming product Customer complaints Audit findings Process deviations Supplier quality issues
• Utilize structured problem-solving methodologies including: 8D 5 Why Fishbone Analysis
• Ensure timely implementation and closure of corrective and preventive actions (CAPA).
• Verify effectiveness of CAPA actions and drive sustainable solutions.
• Monitor recurring quality trends and drive systemic improvements.

Customer Quality Management

• Serve as quality interface for healthcare and medical device customers.
• Lead responses to customer quality issues, complaints, audits and corrective action requests.
• Facilitate customer visits, quality reviews and business review meetings.
• Support customer qualification, product transfers and new product launches.
• Drive customer satisfaction through proactive quality management and continuous improvement activities.

Supplier Quality Management

• Support supplier qualification, monitoring and development activities.
• Review supplier quality performance metrics and drive improvement actions.
• Lead Supplier Corrective Action Requests (SCAR) and supplier investigations.
• Participate in supplier audits and supplier process improvement initiatives.
• Partner with Supply Chain and Procurement teams to ensure supplier compliance.

Validation & Risk Management

• Ensure compliance with validation requirements for:
• Equipment Qualification (IQ/OQ/PQ)
• Process Validation
• Software Validation
• Packaging Validation
• Test Method Validation
• Lead risk management activities in accordance with ISO 14971.
• Participat