ESSENTIAL DUTIES AND RESPONSIBILITIES:
Include the following. Other duties may be assigned:
Document Control System:
• Support Quality function in reviewing all documents inclusive of LHRs, Inspection Reports, Shipment Reports etc.
• Assists 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 timely.
• Reviews and maintains all Quality reports, Validation Protocol reports, records etc. as defined by applicable regulations and standards plus complying to up to date manufacturing processes.
• Ensures 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.
• Train relevant personnel on documentation standards and practices (SOPs), maintain and update the training matrix.
• Review and approve all suppliers of components, raw materials, products, and services which become part of the final product and which directly affect the product quality.
• Maintenance of all applicable records of activities within the Quality System which ensures traceability, accuracy, quality, integrity and accessibility.
Others:
• Undertake any other responsibilities assigned by superior(s) from time to time.
Position Qualifications
Education and/or Experience:
• Diploma or similar field with minimum of 3yrs of progressive Document Control responsibility preferably in the medical device industry.
• Medical Device Manufacturing experience with knowledge of catheter production techniques is preferred.
• Candidate with good Quality Skills of Document Control experience and Engineering background would be considered.
Other Skills:
• Knowledge of GMPs, ISO 13485 and the Medical Device Directives;
• Ability to work with all levels of Company personnel
• Expert in Microsoft Word, Excel and Power Point.
• Quality Skills:
▪ Self-directed and Detailed orientated.
▪ Ability to work independently and being highly motivated.
▪ Dependable and trustworthy.
Work Environment
Controlled Environment (Class 100K cleanroom) and office area.
