Select how often (in days) to receive an alert:QA Post Market ManagerPublished on: Mar 6, 2025Job Category: QualityEmployment type: Regular Full TimeJob ScopeThe QA Post Market Manager is responsible to:Oversee all activities related to the complaint handling process from QA standpointManage the post market surveillance activities to ensure that medical devices continue to be safe and well-performing and to ensure corrective actions are undertaken when necessaryCollect and evaluate experience gained from medical devices that have been placed on the market and to identify the need to take any action or to highlight opportunities to improve.Key Duties and ResponsibilitiesManaging the Post-Market Surveillance process and related deliverables to ensure compliance with all applicable internal and external requirementsEnsuring timely and accurate processing for PMS data collection, plans and periodic reportingOrganizing PMS team, to plan and gather all the information needed for the creation of PMS reports and PlansOverseeing the generation of Post-Market Surveillance plans during the product development.Maintaining up-to-date knowledge on global regulatory requirements for PMS, vigilance and reportingEnsuring the communication of PMS result to product SME, PD, production, customer care and Top ManagementRepresenting the PMS activities as a subject matter expert in support of internal and external auditsOverseeing Complaint processing in compliance with FDA, Health Canada, EU, China and other country specific vigilance regulationsManaging Field Corrective Action Activities and Adverse Event reporting to ensure complianceProvides and verifies the application of the Quality Management System ensuring the adequacy and updating of Quality System with respect to the regulatory and quality requirementsConsistently striving to improve quality according to the highest standardsCooperating with other function to ensure that the process and procedures are in compliance with quality standard (ISO and GMP)providing training and spread the knowledge of the Quality System at all company levelsPerforming internal and external auditCollaborating with technical groups to identify product improvement opportunitiesCollaborating in the definition of the correct risk assessment on the product/process.Education, Experience, and QualificationsDegree in scientific disciplinesKnowledge of regulatory / compliance requirements applicable to in vitro diagnostics / medical devicesAt least five years of Medical Device / -IVD or chemical-pharmaceutical industry experience in similar positionUse of Office packProject ManagementRisk management and related toolsWorking knowledge of FDA Medical Device Regulations including Quality System Regulation 21 CFR Part 820, provides and verifies that the Quality Management System meets the requirements of ISO9001, ISO13485, US FDA QS Regulation (21CFR820) and the Medical Device Regulation (SOR I 98-282) of CanadaStrong analytical skills including trend and statistical analysis Project Management.Strong verbal and written communication skillsSolid problem solving and analytical skillsMarked ability to identify risks associated with a product/process issueSolid interpersonal skills, including ability to negotiate and influence without authorityAbility to supervise team members or to work as part of a teamAbility to manage complex projects and multiple projects (5+) simultaneouslyStrong communication and interpersonal skills with ability to work well in a high-pressure environmentStrong competency in Customer Focus and Driving for ResultsFluent knowledge of the English language
#J-18808-Ljbffr