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Document Control Specialist
3 weeks ago
Description
Quasar, a global B2B medical device manufacturer is looking to hire a Document control specialist, who will join our Quality Department at Singapore. This position Quality System Engineer Engineer
This position will be responsible for assuring that quality documents and records within Quasar Medical Singapore Operations are identified, collected, implemented, revised, indexed, filed, stored and maintained in a manner, which ensures traceability, integrity and accessibility.
- Responsibilities
- Work closely with Quality System Engineer in his/her discharge of his/her Quality System duties.
- 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 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.
- Maintain validation reports, test reports, records, Design History Files, etc. as defined by applicable regulations and standards.
- Assist in all external customer and quality system audits.
- Assist in internal auditing of the Quality System.
- Assist in management of SCAR, MRR, DA, CAPA, complaints and RMA programs.
- Able to work independently to perform multiple tasks in the document control area.
- Requirements
- GCE “O” level or higher, Diploma preferred in technical field or equivalent, with 3~5 yrs of progressive in-depth working experience in maintaining quality records and quality systems, preferably in Medical Device Manufacturing.
- Experience required in developing and/ or enhancing, implementing and maintaining a documentation system which demonstrates compliance with applicable regulatory requirements, or similar document creation, filing and / or archiving.
- Knowledge of Microsoft Word, Excel.
- Knowledge of ISO 9001, ISO13485, FDA 21 CFR Part 820, and/ or the Medical Device Directives.
- While performing the duties of this Job, the employee is frequently exposed to moving mechanical parts. The noise level in the work environment is usually moderate.
- Controlled Environment (Class 10K/100K cleanroom) and office area.
- Position location
- Singapore
