- Bukit Merah Central Region (Singapore) Singapore
Kerja Kerja Dari Rumah Senior Quality Systems Specialist, Gaji tinggi SGD 5,500 di Scalence Central Region (Singapore) - Maukerja
Senior Quality Systems Specialist
Scalence
Kongsi
Simpan
Lokasi Kerja
Penerangan Kerja
Tanggungjawab
Job Title: Senior Quality Systems Specialist
Location:
Singapore (Remote)
Contract Duration:
12 Months
Work Type:
Full-time Contract
Start Date:
As soon as possible
Job Overview
We are looking for an experienced Senior Quality Systems Specialist to support our client’s quality and regulatory compliance activities within the medical device industry. The role will focus on implementing and improving Quality Management Systems (QMS), supporting GDP/GDPMDS certification, and ensuring compliance with Singapore HSA regulatory requirements.
Key Responsibilities
Implement, maintain, and improve ISO 13485-based Quality Management Systems.
Lead and support GDP/GDPMDS certification activities.
Ensure compliance with Singapore HSA medical device regulations.
Prepare and maintain quality documentation, SOPs, and audit records.
Coordinate with certification bodies, accreditation bodies, and regulatory authorities.
Support quality system initiatives for regional operations and commercialization across Southeast Asia.
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.
Strong experience with ISO 13485-based QMS implementation and improvement.
Hands-on knowledge of Singapore HSA regulatory requirements.
Experience supporting or leading GDP/GDPMDS certification projects.
Proven experience in obtaining and maintaining GDP certification.
Experience working with certification bodies and regulatory authorities.
Proficiency in Microsoft Office.
Preferred Experience:
Knowledge of medical device quality and regulatory requirements in Malaysia.
If you have relevant experience and are interested in this opportunity, please share your updated CV along with your contact details.
Scalence is a global leader in IT services, enabling businesses to drive smarter decisions, ensure operational resilience, and deliver superior digital experiences. With decades of expertise and an AI-driven approach, we provide innovative solutions in Data Intelligence, Business Resilience, and Digital Experience, helping organizations stay agile, competitive, and future-ready.
Our robust global delivery framework ensures seamless execution, while our commitment to sustainability drives long-term success. As a proud subsidiary of Artech L.L.C.—the Largest Women-Owned IT Staffing Firm in the U.S., Scalence is dedicated to empowering businesses through transformative IT Project and Managed Solutions. Our clients trust us to navigate their most critical initiatives with precision and confidence.
Location:
Singapore (Remote)
Contract Duration:
12 Months
Work Type:
Full-time Contract
Start Date:
As soon as possible
Job Overview
We are looking for an experienced Senior Quality Systems Specialist to support our client’s quality and regulatory compliance activities within the medical device industry. The role will focus on implementing and improving Quality Management Systems (QMS), supporting GDP/GDPMDS certification, and ensuring compliance with Singapore HSA regulatory requirements.
Key Responsibilities
Implement, maintain, and improve ISO 13485-based Quality Management Systems.
Lead and support GDP/GDPMDS certification activities.
Ensure compliance with Singapore HSA medical device regulations.
Prepare and maintain quality documentation, SOPs, and audit records.
Coordinate with certification bodies, accreditation bodies, and regulatory authorities.
Support quality system initiatives for regional operations and commercialization across Southeast Asia.
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.
Strong experience with ISO 13485-based QMS implementation and improvement.
Hands-on knowledge of Singapore HSA regulatory requirements.
Experience supporting or leading GDP/GDPMDS certification projects.
Proven experience in obtaining and maintaining GDP certification.
Experience working with certification bodies and regulatory authorities.
Proficiency in Microsoft Office.
Preferred Experience:
Knowledge of medical device quality and regulatory requirements in Malaysia.
If you have relevant experience and are interested in this opportunity, please share your updated CV along with your contact details.
Scalence is a global leader in IT services, enabling businesses to drive smarter decisions, ensure operational resilience, and deliver superior digital experiences. With decades of expertise and an AI-driven approach, we provide innovative solutions in Data Intelligence, Business Resilience, and Digital Experience, helping organizations stay agile, competitive, and future-ready.
Our robust global delivery framework ensures seamless execution, while our commitment to sustainability drives long-term success. As a proud subsidiary of Artech L.L.C.—the Largest Women-Owned IT Staffing Firm in the U.S., Scalence is dedicated to empowering businesses through transformative IT Project and Managed Solutions. Our clients trust us to navigate their most critical initiatives with precision and confidence.
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