QA Engineer

Becton Dickinson; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A leading medical technology company in Singapore seeks a Quality Engineer to oversee product quality from assembly to packaging. The ideal candidate will have at least 3 years of relevant experience, a strong understanding of quality management systems, and preferably hold a Six Sigma Green-Belt certification. This role involves data analysis, project management, and ensuring compliance with regulatory standards.

Qualifications

• 3+ years of relevant experience in a quality engineer role.
• Strong understanding of CFR Part 820 and ISO 13485.
• Possession of Six Sigma Green-Belt certification preferred.

Responsibilities

• Oversee product quality from assembly to packaging processes.
• Drive quality improvement and automation projects.
• Support regulatory audits by ensuring compliance.

Skills

Quality Management System knowledge

Data analysis and trending

Project planning

Multi-tasking

Tools

Six Sigma tools

Job description

Overview

Job Description Summary Plan, co-ordinate and oversee all QA support activities and initiatives in the work cell. To improve process capabilities and product quality to meet the desired targets.

Responsibilities

• Oversee the product quality from assembly to packaging process and ensure full compliance to the Quality System and regulation requirements.
• Champion data-driven decisions to resolve non-conformances, complaint investigation, CAPA, deviation and other quality matters in a timely manner.
• Interfaces with R&D, unit quality, customer quality engineer to formulate plans and actions to meet product specifications and quality requirements
• Drive quality improvement/automation projects through project planning, scheduling inspection/testing activities, performing analysis and publishing reports.
• Perform test method validation, installation qualification, correlation study for new quality equipment/test method.
• Act as a support role for regulatory, external, internal and/or supplier audits and lead the value stream members to execute the corrective actions for compliance with customer specifications.
• Perform data analysis and trending for product quality performance through monthly and quarterly management review meeting.
• Establish and maintain effective system and procedures to ensure that all manufacturing and engineering documentation are controlled and updated per established regulatory requirements.
• Supervise quality technical specialist and a group of technicians on quality tests and checks.
• Safety & ISO 14001 Environmental accountability: Ensure a safe, healthy and environmentally-friendly workplace by observing Company €?s rules and procedures. Active involvement in prevention, elimination of potential safety hazards and participation in activities which promotes recycling, replacement and reduction of resource materials.
• Perform any other tasks as assigned.

Preferred Requirements

• 3 years relevant working experiences in a quality engineer role will be advantageous.
• Demonstrated good understanding of key elements of Quality Management system, CFR Part 820, ISO 13485.
• Preferably possess Six Sigma Green-Belt certification or knowledge on six sigma tools.
• Able to effectively multi-task and work independently with a high level of initiative

Work Location and Schedule

Primary Work Location: SGP Tuas - Tuas Plant
Work Shift: SG Normal Office 0745-1645 (Singapore)