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Senior Quality Engineer

2.00 to 3.00 Years   Bangalore   18 Jan, 2023
Job LocationBangalore
EducationNot Mentioned
SalaryNot Disclosed
IndustryMedical / Healthcare
Functional AreaGeneral / Other Software
EmploymentTypeFull-time

Job Description

    Job Description SummaryAs directed by the Quality Manager, the Sr. Quality Engineer is accountable for supporting new product development and product maintenance through the application of Quality engineering skills for medical devices. This person will handle projects and tasks, from product inception through product launch and maintenance and play an active role in the processes to ensure products meet quality standards consistent with both Corporate and unit policies, while meeting all design control and other regulatory requirements. Job Description Primary Responsibilities and Dutie s Responsibilities:1Consistent application of technical principles, theories, concepts and quality sciences / tools.2Proven problem solving skills.3Makes measureable improvements to BD processes and procedures.4Ensures that all design control and production / process control projects meet applicable regulatory (local and international), Corporate, and Unit requirements.5Is a team member representing Quality on new product development and sustaining engineering projects.6Reviews and has Quality Engineering approval authority for new and modified design / process specifications including product performance specifications, test methods, etc.7Assists with supplier and internal quality system audits as a means of evaluating the effectiveness of the established Quality System and Good manufacturing Practices (Auditor-in-Training).May perform other duties as requiredPosition-Specific Overview: Position specific responsibilities include support of the following, however are not limited to:Design ControlDesign InputDesign OutputDesign Verification plans, protocols, and reportsDesign ReviewsDesign ValidationDesign History File supportChange controlAssessment of Change Request (ACR) ResponsesRisk ManagementProcess ValidationsIdentification of CTQsUnit Quality Independent Reviewer During Design ReviewsHandling of deviations and non-conformancesTest method validationsSupplier qualificationSoftware validationsPost Market SurveillanceSituation AnalysisCAPA Root cause investigation and implementation of corrective / preventive actionsProper Use of Statistics (Sampling Plans)Advise on RegulationsLiaise with Manufacturing PlantsProvide functional support to cross-functional teamsInternal and external auditsScope of Responsibility: Strategic Orientation:Contributes to the completion of specific programs and projects.Ensures quality conduct of projects, including design, data summary and interpretation and report generation for self and lower level project developers.Prepares/Revises policies/procedures.Sphere of Influence:Works under general direction.Independently determines and develops approach to solutions.May provide guidance and work direction to other team membersDesigns and performs development working independently within defined parameters with minimal supervision requiredPrimary Work LocationIND Bangalore - Technology Campus Additional Locations Work Shift,

Keyskills :
quality controlppapinspectionqualityisonew product developmentcontinuous improvement facilitationroot causesystem auditproduct launchdesign control

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