
Post Market Surveillance Manager
4 days ago
Job Description:
We are seeking a highly skilled and experienced Post Market Surveillance Manager to join our team.
Main Responsibilities:
- To manage the post market surveillance activities in accordance with regulatory requirements, including FCA, Recall & FSCA, AE, and other QM related matters.
- To ensure the quality level of management and products is maintained and enhanced.
- To support all QMS audits in accordance to ISO 9001, 13485 & 14001 in the AP territory with respect to FSCA/FCA.
- To manage the QM/QA aspects in review, design change, Change Request and finalisation of the CSV related documentation for SW and hardware.
- To 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.
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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