Document Controller & QA Executive (CEQ/ISO Certification)

SEARCH PERSONNEL PRIVATE LIMITED; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A leading manufacturer of life‑saving devices in Singapore is looking for a Document Controller & QA Executive to sustain and improve their Quality Management System. This role involves executing quality assurance initiatives, maintaining compliance with international standards, and ensuring that documentation meets regulatory requirements. Ideal candidates should have a Bachelor's degree in life sciences or engineering, at least 2 years of relevant experience, and be proficient in quality assurance techniques and Microsoft Office.

Benefits

AWS

Staff Benefits

Qualifications

• 2 years of experience in Quality Assurance or related field.
• Prefer CEQ/ISO Certification.
• Familiarity with Quality Assurance techniques.

Responsibilities

• Sustain an active Quality Management System.
• Participate in the establishment and implementation of SOP.
• Monitor external standards and regulatory requirements.
• Implement and maintain management system compliance.

Skills

Knowledge of Quality Management System

Knowledge of ISO 13485

Proficient in Microsoft Office (Word, PowerPoint, Excel)

Excellent communication skills

Education

Bachelor's Degree in life sciences, engineering, or equivalent

Job description

Position: Document Controller & QA Executive

Location: Admiralty

Working hours: Monday to Friday (8.30am - 5.30pm)

Salary (commensurate with experience): Up to $4,800 + AWS + Staff Benefits

Duration: Permanent

Industry: Manufacturer of life‑saving & life‑enhancing devices

Main Responsibilities:

• Sustain an active Quality Management System such as Management Review, Internal Audit, Document Control, Product Release and Training.
• Participate in the establishment, verification and implementation of SOP to comply with company needs and regulatory requirements.
• Participate in the development of QA strategies and recommendations for continual improvement in conjunction with company needs.
• Monitor external standards such as design standards (ISO, IEC), European harmonized standards, FDA policies and guidance, Industry Journals and National/International regulatory requirements.
• Implement and maintain the management system compliance with relevant international quality standards and regulatory requirements (ISO 13485, ISO 14971, MDR 2017/745, 21 CFR part 820).
• Interface with inspectors, NB Auditors during inspection and provide post‑inspection follow‑up information as requested.
• Execute day‑to‑day quality assurance activities, facilitate and implement improvements to the quality system while maintaining compliance with applicable Quality System Regulations and ISO standards.
• Ensure the documentation system complies with regulatory and ISO requirements.
• Maintain QMS, DHF, DMR, DHR and Technical Files.

Requirements:

• Bachelor’s Degree in life sciences, engineering, or equivalent with 2 years of experience.
• Prefer CEQ/ISO Certification.
• Knowledgeable with the Quality Management System and ISO 13485, US FDA 21 CFR part 820.
• Knowledge of MDR 2017/745 Medical Device Regulation requirements.
• Familiarity with Quality Assurance techniques.
• Proficient in Microsoft Office (Word, PowerPoint, Excel).
• Excellent communication skills.

For more information, please email [e-mail].

Thank you for your interest in this position. Our shortlisting period is 3 working days. Only shortlisted candidates will be contacted for further consideration.

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