Document Controller & QARA Executive

• 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: for more information.

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...We do not charge our candidates any referral fee nor bind them with any contract....

Abby Pang

Deputy Consulting Director (APAC)

Reg no.: R2093867

EA No: 13C6684

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

If you do not receive communication from us within this timeframe, it's likely that your application has not been shortlisted by our client. In such cases, we recommend that you continue your job search to maximize your opportunities. We wish you all the best and should we have any suitable roles that match your experiences/ qualifications/ preferences, we will reach out to you.