QA Engineer

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

Job summary

A global medical technology company is looking for a Quality Engineer in Singapore to oversee product quality, manage non-conformances, and drive quality improvement projects. The ideal candidate will have at least 3 years of relevant experience and a strong understanding of quality management systems, particularly ISO 13485. The position involves supervising a team and ensuring compliance with regulatory requirements.

Qualifications

• 3 years relevant working experience in a quality engineer role.
• Good understanding of CFR Part 820 and ISO 13485.
• Preferably possess Six Sigma Green-Belt certification.

Responsibilities

• Oversee product quality from assembly to packaging.
• Resolve non-conformances and conduct investigations.
• Drive quality improvement projects and publish reports.
• Supervise quality technical specialists and technicians.

Skills

Quality Management system knowledge

Data analysis

Project management

Six Sigma tools knowledge

Job description

Job Description Summary

Plan, coordinate and oversee all QA support activities and initiatives in the work cell. To improve process capabilities and product quality to meet the desired targets.

Job Description

• 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.

Required Skills

Optional Skills

Primary Work Location

SGP Tuas - Tuas Plant

Work Shift

SG Normal Office 0745-1645 (Singapore)