Document Control Clerk

Quasar Medical (Singapore) Pte Ltd; Singapore; On-site; SGD 39,060 - 61,380; Full time

Job summary

Quasar Medical (Singapore) Pte Ltd is seeking a detail-oriented Document Control Specialist to support the Quality System in a medical device environment. You will ensure controlled documents are created, revised, archived, and accessible in compliance with ISO 9001, ISO13485, and FDA requirements.

You will collaborate with Quality and Engineering teams to maintain DHFs, validation and change control, and to prepare for internal and external audits.

Qualifications

• GCE “O” Level or higher; Diploma preferred in a technical field or equivalent, with 3–5 years of progressive in-depth experience in maintaining quality records and quality systems, preferably in Medical Device Manufacturing.

Responsibilities

• Work closely with Quality System Engineer in his/her discharge of his/her Quality System duties.
• Lead in the released of documents for the NPI - New Product Introduction to ensure it meets the QMS requirements.
• Works with the Engineering and Project team in the final hand over of controlled document deliverables.
• Ensure that documentation and records that relate to the requirements of the Quality System are controlled in a manner, which ensures traceability, integrity and accessibility.
• Develop, enhance and revise documentation procedures, implements necessary updates, and maintains all required documents as defined by applicable regulations.
• Train relevant personnel on documentation standards and practices.
• Assist relevant personnel in the creation of Change Plan (CP) / Engineering Change Order (ECO) packets for compliance with established requirements. Reviews all such packets, resolves issues with the initiator of the change, and enters the document into the Document Control System.
• Ensure that the current revision of a controlled document is clearly defined in order to preclude the use of non-applicable documents and promptly removes any obsolete documents from all points of issue or use.
• Communicate and promote awareness of document control systems, processes and standards where required
• Monitor of log sheets management for CP/ECO, SCAR, NC, DA, CAPA, complaints, RMA, etc
• Maintain validation reports, test reports, records, Design History Files, etc. as defined by applicable regulations and standards.
• Assist and monitor weekly meeting of NC and CAPA
• Assist in all external customer and quality system audits.
• Assist in internal auditing of the Quality System.
• Assist in management of SCAR, NC, DA, CAPA, complaints and RMA programs.
• Able to work independently to perform multiple tasks in the document control area.

Skills

Document control

Quality systems

Regulatory knowledge

MS Office

CAD tools

Audit support

Education

Diploma in a technical field

GCE O level or higher

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Electronic filing system

Job description

Essential Duties and Responsibilities:

Include the following. Other duties may be assigned.

• Work closely with Quality System Engineer in his/her discharge of his/her Quality System duties.

• Lead in the released of documents for the NPI - New Product Introduction to ensure it meets the QMS requirements.

• Works with the Engineering and Project team in the final hand over of controlled document deliverables.

• Ensure that documentation and records that relate to the requirements of the Quality System are controlled in a manner, which ensures traceability, integrity and accessibility.

• Develop, enhance and revise documentation procedures, implements necessary updates, and maintains all required documents as defined by applicable regulations.

• Train relevant personnel on documentation standards and practices.

• Assist relevant personnel in the creation of Change Plan (CP) / Engineering Change Order (ECO) packets for compliance with established requirements. Reviews all such packets, resolves issues with the initiator of the change, and enters the document into the Document Control System.

• Ensure that the current revision of a controlled document is clearly defined in order to preclude the use of non-applicable documents and promptly removes any obsolete documents from all points of issue or use.

• Communicate and promote awareness of document control systems, processes and standards where required

• Monitor of log sheets management for CP/ECO, SCAR, NC, DA, CAPA, complaints, RMA, etc

• Maintain validation reports, test reports, records, Design History Files, etc. as defined by applicable regulations and standards.

• Assist and monitor weekly meeting of NC and CAPA

• Assist in all external customer and quality system audits.

• Assist in internal auditing of the Quality System.

• Assist in management of SCAR, NC, DA, CAPA, complaints and RMA programs.

• Able to work independently to perform multiple tasks in the document control area.

Education/Experience and Qualifications:

• GCE “O” Level or higher; Diploma preferred in a technical field or equivalent, with 3–5 years of progressive in-depth experience in maintaining quality records and quality systems, preferably in Medical Device Manufacturing.

• Experience in developing, enhancing, implementing, and maintaining a documentation system that demonstrates compliance with applicable regulatory requirements, or similar document creation, filing, and/or archiving.

• Excellent Communication Skills.

• Proficiency in Microsoft Word, Excel, and Power Point. Preferably has experience with electronic filing, database administration and/ or CAD software drawing.

• Ability to perform activities to support product development, manufacturing, and release as identified by Senior Management;

• Knowledgeable in writing manufacturing procedures and GMP requirements

• Knowledge of ISO 9001, ISO13485, FDA 21 CFR Part 820, and/ or the Medical Device Directive.