QARA & Document Control Lead – ISO/FDA Expert

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

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.