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Senior QM Specialist
2 weeks ago
Key Job Purpose:
Manage the Post Market Surveillance management (FCA, Recall & FSCA, AE), and other QM related matters in AP region to comply with the law, regulations and requirementas well as keep enhancing quality level of management and products. Support all QMS audits in accordance to ISO 9001, 13485 & 14001 in the AP territory with respect to FSCA/FCA.
Manage the QM/QA aspects in review, design change, Change Request and finalisation of the CSV related documentation for SW and hardware. Ensure all CSV processes and documentation is in full compliance with the Sysmex QMS, all relevant standards (cGMP, GAMP, ER/ES) and other related standards and regulations. As RHQ Subject Matter Expert (SME) for post-market activities and CSV, shall provide regional guidance and support to all Affiliates on these assigned aspects.
QM representative in ISO27001:2022 Information Security Management System (ISMS) project and support the Project Manager in establishing and implementing ISO27001 and attaining certification per project plan. Support the scope expansion of ISO27001:2022 per business direction. Compliance maintenance to ISO27001:2022 subsequently.
Job Description:
Ensure the establishment and maintenance of SAP's QMS to the latest ISO 13485 QMS, FSCA/FCA and CSV-equivalent requirements.
Develop and execute quality strategies to enhance the company efficiency and effectiveness pertaining FCA/FSCA, product recall and CSV/SDLC.
Initiate, lead and monitor the execution FCA, Recall & FSCA, AE, and other postmarket surveillance related activities with customer care and any other relevant departments within Sysmex AP affiliates and business partners and manufacturers.
Manage the business change control and quality impact pertaining to FSCA/FCA and CSV related activities at SAP and provide guidance and support to affiliates. Work with affiliates process owner(s) to ensure the initiation and implementation of post-market activities are in accordance with regional and site procedures. Facilitate a continuous improvement culture in Post-market activities within SAP and extends to affiliates QA.
Perform and lead computer system validation activities related to authoring and executing specifications and validation documentation for process and systems according to the GAMP5 Validation Life Cycle related to software development/testing life cycle.
Review and support the execution of Computer System Validation and ensure compliance, adherence with corporate guidelines procedures, CGMP and GAMP guidelines and regulations.
Mentor affiliates CSV leads in their validation activities to be in compliance with the related regulations, procedures and local requirements.
Support the establishment and implementation of ISO27001: 2022, jointly with QM Manager. Support appointed Project Manager and QM Manager to attain ISO27001 certification.
Getting the organization ready for ISO27001: 2022 should there be any scope expansion. Jointly with QM Manager, execute the maintenance of ISO27001 QMS accordingly.
Support Corporate Auditors on CSV or software related validation associated with infrastructure and non-product related.
Execute any tasks given by supervisor or SAP's management.
Job Requirements :
Bachelor's Degree in Engineering or Science
5 years of Quality Management experience in Medical Device industry.
3 years of CSV documentation & processes validation.
Lead auditor certification to ISO 13485:2016, ISO 9001: 2015, ISO 27001: 2022.
Well-versed in QMS and SDLC, ERP (21 CFR Parts 11, 210 and 820).
Good understanding of computer systems / software used in various companies in the medical industry.
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