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Open nowPosted today

Senior Quality Systems Specialist

SCALENCE PTE. LTD.

Pay
SGD 4,500 – SGD 5,500 a month
Where
Central, Singapore
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Your applicationOpen nowSenior Quality Systems SpecialistSCALENCE PTE. LTD. · Central, Singapore

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Share of postings closed within
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  2. 4.5%3 days
  3. 12.3%7 days
  4. 19.7%14 days
  5. 35.6%30 days
  6. 58.0%60 days
This job: posted today

The posting

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.

Posting text belongs to the employer. Removal requests: contact us.

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