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| Job Location | Bangalore |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Medical / Healthcare |
| Functional Area | General / Other Software |
| EmploymentType | Full-time |
Around 8- 15 Experience in Software Quality Assurance Experience as senior software/ hardware engineer/ module leader/ technical leader Working experience in quality assurance and Regulatory assurance Preferable experience in all areas of Software development life cycle Diploma/ Graduate/ Post graduate in Electronic Engineering/ Software Engineering with 8- 15 of experiencePractical knowledge of prevailing software/ hardware quality standards and models Process auditing skills Exposure to applicable regulatory standards such as ISO 13485, FDA 21 CFR 820, IEC 62304 is MANDATORY Role To perform both the functions of a Quality Assurance and Regulatory Assurance role in Medical Device Industry To monitor the status and progress of the project independently To advice project management on perceived risks in the project Responsibilities and Key Result Areas: Software Quality engineering activities: Process deployment Participation in process definition as per Sector/ BU standards, tailoring as per project needs and effective deployment Conducting configuration audits along with the QL/ Program Quality Conducting process audits and compliance checks Initiating necessary escalations in case of non- compliance Active Participation in Development Process Ensuring that the reviews are conducted effectively and also that the review comments are closed and incorporated in the work products Ensuring that only the reviewed and tested code is used for integration Ensuring release worthiness of all deliverables Metrics data collection for the project and analysis, initiating and tracking corrective / preventive actions with the PL Defect classification and analysis, initiating and tracking corrective/ preventive actions with the PL Co- coordinating for project Stage reviews and Audits; ensuring that lessons learnt in project are captured, shared, & acted upon. Interface with global counterparts during software releases, audit and acceptance.,
Keyskills :
program classification fda iec quality standards ctivities project kingexperience functions