Global QMS Leader - Medical Devices & Compliance

5G-Starlink Pte.; Singapore; On-site; SGD 90,000 - 120,000; Full time

Job summary

A leading technology company in Singapore seeks a Quality System Manager to develop and implement a robust Quality Management System (QMS). The role requires at least 5 years of experience in managing quality systems within regulated industries, with responsibilities including ensuring compliance with FDA and ISO standards, leading quality improvement initiatives, and overseeing audits. Ideal candidates possess strong leadership and analytical skills, and a degree in Engineering or relevant experience. This position may require traveling up to 25% primarily to the US and Europe.

Qualifications

• 5+ years of experience in management of product quality in regulated industry.
• Managed external audits of Notified Bodies, preferably FDA.
• Familiar with Quality System Regulation, ISO 13485, MDSAP.

Responsibilities

• Develop and sustain the Quality Management System (QMS).
• Lead the Quality System function to ensure compliance with regulations.
• Support management of CAPA as required.

Skills

Quality Orientation

Continuous improvement

Technical and professional knowledge in Quality Assurance

Project Management skills

Excellent Communication skills

Analytical skills

Education

Degree in Engineering or equivalent

Formal education on Quality Management

Tools

MasterControl platform

Microsoft Office

Power BI

Job description

A leading technology company in Singapore seeks a Quality System Manager to develop and implement a robust Quality Management System (QMS). The role requires at least 5 years of experience in managing quality systems within regulated industries, with responsibilities including ensuring compliance with FDA and ISO standards, leading quality improvement initiatives, and overseeing audits. Ideal candidates possess strong leadership and analytical skills, and a degree in Engineering or relevant experience. This position may require traveling up to 25% primarily to the US and Europe.