Document Controller and QARA Executive

Search Personnel Pte Ltd; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A healthcare device manufacturing firm is seeking a Document Controller & QARA Executive in Singapore. The role involves sustaining Quality Management Systems, ensuring compliance with ISO standards, and interfacing with regulatory auditors. Ideal candidates will have a Bachelor's degree in life sciences or engineering and at least 2 years of QA experience. Competitive salary of up to $4,800 with benefits. Interested applicants should contact for more information.

Benefits

AWS

Staff Benefits

Qualifications

• Bachelor’s Degree in life sciences, engineering, or equivalent with 2 years of experience.
• Prefer CEQ/ISO Certification.
• Knowledgeable with ISO 13485 and US FDA 21 CFR part 820.
• Knowledge of MDR 2017/745 Medical Device Regulation.

Responsibilities

• Sustain and maintain Quality Management System and Document Control.
• Assist in the establishment and implementation of SOPs.
• Monitor external standards and regulatory requirements.
• Interface with inspectors and manage quality assurance activities.

Skills

Knowledge of Quality Management System

Familiarity with Quality Assurance techniques

Excellent communication skills

Proficient in Microsoft Office

Education

Bachelor’s Degree in life sciences or engineering

Job description

• Position: Document Controller & QARA 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 and active Quality Management System such as Management Review, Internal Audit, Document Control, Product Release and Training
• Participate and assist for establishment, verification and implementation of SOP to comply with the company needs and regulatory requirements
• Participate and assist in the development of QA strategies, recommendations for continual improvement in conjunction with the needs of the company
• Monitor external standards such as design standards (ISO, IEC), European harmonized standards, FDA policies and guidance, industry journals and national/international regulatory requirements
• Participate in the implementation and maintenance of the management system compliance with relevant international quality standards and regulatory requirements (Such as ISO 13485, ISO 14971, MDR 2017/745, and 21 CFR part 820)
• Interface with inspectors, NB Auditors during inspection and provide post‑inspection follow‑up information as requested
• Manage day‑to‑day execution of the 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
• To 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, etc.)
• Excellent communication skills

Email to: [e-mail] for more information.