SQA Engineer

3 months ago

Pune, India L4B Software Full time

PositionOverview:
L4B Softwareis seeking a dedicated and skilled SQA Engineer or Senior SQAEngineer with expertise in Quality Management Systems and MedicalDevice Software Development. The ideal candidate will possessstrong experience in process definition quality management andcompliance with international standards and FDA regulations. Thisrole involves handling customer complaints managing customersatisfaction programs and assessing risks and safetyclassifications for medical devices andsoftware.

KeyResponsibilities:

  • Defineimplement and maintain SQA processes including SEPG/PEG and QMStemplates.
  • Build and improveprocesses aligned with international standards and businessneeds.
  • Ensure compliance with ISO13485 or ISO 62304 standards.
  • Workwithin the Medical Device Software Development Industry or MedicalDevice GMP.
  • Understand and apply FDAregulations for medical devices or medical devicesoftware.
  • Manage customer complaintsand lead customer satisfactionprograms.
  • Assess risks and determinesafety classifications for medical devices andsoftware.
  • Communicate effectivelywith stakeholders and manage projectsefficiently.
  • Utilize advanced MSOffice applications (Word Excel PowerPoint Microsoft Formsetc.).
  • Apply knowledge of SDLC andquality tools to ensure productquality.


Requirements

RequiredQualifications:

  • Bachelors or master s degree in a relevantfield.
  • 24 years of experience in SQAprocess definition QMS and relatedareas.
  • Proficiency in building andimproving QMS processes.
  • Knowledgeof ISO 13485 or ISO 62304standards.
  • Experience in the MedicalDevice Software Development Industry or Medical DeviceGMP.
  • Familiarity with FDAregulations for medical devices orsoftware.
  • Strong communication andmanagement skills.
  • Advanced skillsin MS Officeapplications.
  • Understanding of SDLCand qualitytools

DesiredSkills:

  • Abilityto handle customer complaints and manage customer satisfactionprograms.
  • Competence in assessingrisks and determining safetyclassifications.
  • Excellentproblemsolving and analyticalskills.
  • Team player witha proactiveapproach

BenefitsWhatWeOffer:
  • HealthInsurance:Ensure peace of mind with ourcomprehensive health insurance coverage offering you and yourfamily access to highquality healthcare whenevernecessary.
  • ProvidentFund Contribution:Our company provides aprovident fund policy with contributions from both the employer andemployee. This collaborative effort actively builds your retirementsavings establishing a robust financial foundation for yourfuture.
  • HybridWork Mode and Flexible WorkingHours:Embrace flexibility throughour hybrid work mode allowing you to work remotely for two daysfrom home and spend three days in the office. Take charge of yourschedule with our flexible working hours policy empowering you tomanage personal appointments and commitmentseffectively.
  • OpenFridge Policy:Foster a positive atmospherein our office with an open fridge policy. Enjoy a diverse selectionof beverages and snacks freely available to all employees keepingyou refreshed throughout theday.
  • InternationalExpert Team:Collaborate with a diverseteam of international experts to broaden your professionalhorizons. Learn and work alongside professionals from differentbackgrounds fostering personal and careergrowth.


Required Qualifications: Bachelor s or master s degree in arelevant field. 2-4 years of experience in SQA, process definition,QMS, and related areas. Proficiency in building and improving QMSprocesses. Knowledge of ISO 13485 or ISO 62304 standards.Experience in the Medical Device Software Development Industry orMedical Device GMP. Familiarity with FDA regulations for medicaldevices or software. Strong communication and management skills.Advanced skills in MS Office applications. Understanding of SDLCand quality tools Desired Skills: Ability to handle customercomplaints and manage customer satisfaction programs. Competence inassessing risks and determining safety classifications. Excellentproblem-solving and analytical skills. Team player with a proactiveapproach

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