Associate Director, Quality - FONG'S ENGINEERING AND MANUFACTURING PTE LTD

Roles & Responsibilities

• Manage the company’s Quality System in compliance with ISO13485 and applicable regulatory requirements, ensuring that the Quality System requirements are effectively implemented, maintained, and reviewed to be suitable for company's contract manufacturing operations. Establish Quality Policies and develop monitoring plans to ensure that Quality Objectives are met.
• Lead Management Review meetings to report quality system metrics timely. Identify resource and execution gaps to the management team and propose improvement plans to meet quality objectives and business goals.
• Host external auditors as the company’s Quality Management Representative . Interact with external auditors professionally and address any audit findings promptly and effectively.
• Lead / Mentor team of internal auditors to perform regular Internal Quality Audit , communicate audit findings to the company, determine Corrective and Preventive Actions (CAPA) and monitor CAPA effectiveness.
• Manage department of quality engineers, specialists, technicians, and inspectors to ensure quality processes are executed throughout the Product Realization cycle and products are manufactured in compliance to product specifications and regulatory requirements.
• Oversee all complaints are logged in the Complaint Handling system. Ensure complaints are investigated promptly, root cause identified, CAPA executed and CAPA effectiveness verified.
• Oversee Supplier Quality Management activities such as supplier qualification, supplier risk assessment, supplier audit and supplier performance monitoring.
• Oversee Document Control and Record Control . Ensure creation, approval routing, revision control, distribution, and retrieval activities for SOPs, WIs, FORMs, etc. are performed in accordance with document and record control requirements.
• Provide quality engineering leadership in Nonconformance Handling , Statistical Techniques , Root Cause Analysis , Corrective and Preventive Actions , Process Validation , Risk Analysis, and other related technical skills. Ensure adequacy of training for all engineers.
• Champion continuous improvement initiatives. Promote culture of quality, continuous improvement, and data-driven decisions.
• Prepare annual budget for quality department to meet quality and business goals.

Tell employers what skills you have

Leadership

CAPA

Quality Control

Risk Assessment

Supplier Quality

Quality Management

Quality System

ISO

Root Cause Analysis

Risk Management

Process Validation

problem solving skills

Manufacturing Operations

Compliance

Quality Engineering

Statistical Analysis

Regulatory Requirements

Audit