Document Controller and QARA Executive

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

Job summary

A life-saving devices manufacturer in Singapore is seeking a Document Controller & QA Executive to manage the Quality Management System and ensure compliance with ISO and FDA standards. Candidates must hold a Bachelor’s degree in life sciences or engineering with 2 years of relevant experience. Proficiency in Microsoft Office and knowledge of ISO 13485 and FDA regulations are essential. The role offers a salary up to $4,800 along with AWS and other staff benefits. Email for inquiries.

Benefits

AWS

Staff Benefits

Qualifications

• 2 years of experience in quality management or related field.
• Prefer CEQ/ISO Certification.
• Knowledge of US FDA 21 CFR part 820.

Responsibilities

• Maintain Quality Management System compliance.
• Monitor external standards and regulatory requirements.
• Interface with inspectors and manage QA activities.

Skills

Knowledge of Quality Management System

ISO 13485

Excellent communication skills

Proficiency in Microsoft Office

Familiarity with Quality Assurance techniques

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 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.