Senior Quality Systems Specialist- Singapore based remote role /

Artech Infosystems Private Limited; Singapore; A distancia; SGD 90.000 - 150.000; Jornada completa

Descripción de la vacante

Artech Infosystems Private Limited is seeking a Senior Quality Systems Specialist to drive QMS implementation and continuous improvement for medical devices in Singapore. You will lead GDP/GDPMDS certification efforts and ensure compliance with Singapore HSA regulations across regional operations.

The role requires strong knowledge of Singapore medical device regulations, ISO 13485, and hands-on experience leading quality initiatives.

Formación

• Bachelor's degree in Life Sciences or related field.
• 5–7 years QA/QMS in the medical device sector.
• Hands-on ISO 13485 QMS implementation and improvement.

Responsabilidades

• Implement, maintain and improve ISO 13485-based QMS.
• Lead GDP/GDPMDS certification and compliance activities.
• Ensure Singapore HSA regulatory compliance for medical devices.
• Coordinate with certification bodies and regulatory authorities.
• Prepare and maintain quality documentation and audit records.
• Collaborate with cross-functional teams for certification and commercialization.
• Support Southeast Asia quality system activities, including Malaysia.

Conocimientos

QA/QMS experience

ISO 13485 knowledge

GDP/GDPMDS certification experience

HSA regulatory knowledge

Regulatory project leadership

Educación

Bachelor's degree in Life Sciences or related

Descripción del empleo

Senior Quality Systems Specialist

Location: Singapore | Work Type: Remote

Contract Duration: 12 Months

Job Overview

We are looking for an experienced Senior Quality Systems Specialist to support Quality Management System (QMS) implementation, maintenance, and continuous improvement within the medical device industry. The role will focus on Singapore HSA regulatory compliance, ISO 13485 standards, and GDP/GDPMDS certification to support regional operations and commercialization.

The ideal candidate should have strong knowledge of Singapore medical device regulations and the ability to independently lead quality and certification initiatives.

Key Responsibilities

• Implement, maintain, and improve ISO 13485-based Quality Management Systems.
• Lead and support GDP/GDPMDS certification and compliance activities.
• Ensure compliance with Singapore HSA medical device regulatory requirements.
• Coordinate with certification bodies, accreditation bodies, and regulatory authorities.
• Prepare and maintain quality documentation, procedures, and audit records.
• Collaborate with cross-functional teams to support certification and commercialization.
• Support regional quality system activities across Southeast Asia, including Malaysia where applicable.

Required Qualifications

• Bachelor's degree or higher in Life Sciences or a related discipline.
• 5–7 years of experience in Quality Assurance or Quality Systems within the medical device industry.
• Hands-on experience implementing or improving ISO 13485-based QMS.
• Strong knowledge of Singapore HSA regulatory requirements.
• Demonstrated experience supporting or leading GDP/GDPMDS certification projects.
• Proven track record in obtaining and maintaining GDP certification.
• Experience working with certification bodies, accreditation bodies, and regulatory authorities.
• Proficiency in Microsoft Office applications.

Preferred: Experience with medical device quality systems and regulatory requirements in Malaysia.

Contract: 12 months

Work Arrangement: Remote