ASSOCIATE DIRECTOR, QUALITY

Fong's Engineering & Manufacturing Pte Ltd; Singapore; On-site; SGD 70,000 - 95,000; Full time

Job summary

A manufacturing firm in Singapore is looking for a Quality Manager to oversee the compliance of the Quality System with ISO13485. The role involves leading audit processes, managing a quality team, and ensuring the effectiveness of corrective actions. Ideal candidates will have experience in quality systems within manufacturing and strong leadership skills.

Qualifications

• Proven experience in managing Quality Systems, preferably in a contract manufacturing environment.
• Strong understanding of ISO13485 and regulatory requirements.
• Excellent leadership and mentoring skills.

Responsibilities

• Manage the company’s Quality System in compliance with ISO13485.
• Lead Management Review meetings and propose improvement plans.
• Host external auditors and address audit findings effectively.
• Lead a team of internal auditors to monitor audit effectiveness.
• Manage quality engineering department and ensure compliance.

Job description

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 the 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.