You may be assigned as Level 2 AMS support between Business/Client IT Team, partnering systems, and Application Managed Services (AMS) team. In this role, you are expected
Ensure the compliance of QMS towards applicable medical devices regulations and standards, in area of QMS processes such as Audits, CAPA, Change Control Management, Documentation/Records Management and Training.
Represent Enterprise Singapore to interact independently and directly with external members of public and resolve escalated or complex public enquiries received on EnterpriseSG’s programmes and assistance.
Location: Gul Circle (Pick up @ Choa Chu Kang / Jurong East / Woodlands)Duration: 6 MonthsSalary: $2300Working days and hours:- 8am to 5.15pm, Monday to Friday (with 45mins lunch break, 15mins tea break)Job Description:- Perform QC testing and review of QC data to support the timely release of GeneChip arrays.- Provide data trending and assist team leads in troubleshooting failure analysis. Technical duties- Perform QC testing of GeneChip products to ensure compliance with quality specifications, particularly in compliance with ISO 13485, MDSAP and 21- CFR – 820 requirements.- Perform target preparation for Cytoscan and Axiom.- Perform review and disposition of QC batch records for release to QA.- Perform preventive maintenance for QC equipment.- Schedule QC testing and target preparation- Support and conduct in lab investigation relating to product failures & participate in the implementation of corrective actions as necessary.- Support and conduct experiment /analysis to support new product release & enhancement of test methods.- Trending & monitoring of QC test data to support failure analysis, investigation & troubleshooting.- Perform QC updates at daily Tier 1 meeting.- Support FQC Supervisor in accomplishing tasks as assigned. Administrative duties- Ensure controlled documents to support QC operation are properly maintained and readily available.- Provide training to other junior employees and QC staff as required.Job Requirements:- Min Diploma in Biomedical Engineering, Biomedical Science, Biotechnology or any relevant field