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: abby.pang@searchpersonnel.com.sg for more information
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