QA Manager

4 weeks ago

Mumbai, India Suvarna and Associates Full time
Opening: QA Manager in RiyadhSaudiArabia
Weare seeking a QA Manager for an emerging Medical Device Company inRiyadh Saudi Arabia specializing in Advanced Wound Care andInfection Management. The company is in the early stages ofproduction and is preparing to bring its products to market in thecoming months. This is an exciting opportunity to join anexceptional team and gain internationalexposure.The first round of interviews willbe conducted online with the final interview taking place in Mumbai(details to be provided uponinitiation).
JobDescription andQualifications
Education:
  1. Required:Bachelor s degree in engineering life sciences or a related field.Common degrees include Biomedical Engineering MechanicalEngineering orBiochemistry.
  2. Preferred:Advanced Degree (Master s or higher) in a specialized field or forhigherlevelpositions.

Experience:
  1. IndustryExperience: 510 years in the medical device industrywith a focus on quality assurance quality control or regulatoryaffairs.
  2. ManagementExperience: 35 years in a managerial or supervisoryrole overseeing QA teams andprocesses.
  3. RegulatoryKnowledge: Extensive experience with regulatoryrequirements such as ISO 13485 and other relevantstandards.

SkillsandCompetencies:
  1. QualityManagement Systems (QMS): Indepth knowledge andexperience in implementing and maintainingQMS.
  2. Auditing:Experience in conducting internal and external audits includingsupplieraudits.
  3. ProblemSolving:Strong analytical skills for addressing quality issues andimplementing corrective and preventive actions(CAPA).
  4. Documentation:Proficiency in developing reviewing and managing qualityrelateddocumentation.
  5. Communication:Excellent skills for coordinating with crossfunctional teams seniormanagement and regulatorybodies.
  6. Attention toDetail: High attention to detail to ensurecompliance and productquality.
  7. Leadership:Strong leadership skills to effectively manage and mentor QA teammembers.
  8. LanguageSkills: Fluent in verbal and writtenEnglish.

JobResponsibilities:
  • Correctiveand Preventive Actions (CAPA): Implement and manageCAPA processes to address product and processnonconformities.

  • SupplierQualityManagement:

  1. SupplierEvaluation: Evaluate and approve suppliers conductsupplier audits and monitor supplierperformance.
  2. IncomingInspection: Ensure the quality of incoming materialsthrough inspection andtesting.

  • ContinuousImprovement:

  1. ProcessImprovement: Identify and implement processimprovements to enhance quality andefficiency.
  2. Training andDevelopment: Provide training on quality policiesprocedures and regulatoryrequirements.

  • ComplaintHandling and PostMarketSurveillance:

  1. ComplaintInvestigation: Manage the investigation of customercomplaints and ensure timelyresolution.
  2. PostMarketSurveillance: Oversee activities to monitor productperformance and safety in thefield.

  • TeamLeadership:

  1. TeamManagement: Lead and mentor the QA team providingguidance andsupport
  2. CrossFunctionalCollaboration: Work with other departments (e.g.R&D manufacturing regulatory affairs) to ensure qualityobjectives aremet.

  • Reporting:

  1. QualityMetrics: Develop and track key quality metrics andgenerate regular reports for seniormanagement.
  2. ManagementReviews: Conduct reviews to evaluate theeffectiveness of the QMS and identify areas forimprovement.

documentation,problem-solving,cross-functionalcollaboration,continuous improvement,reporting,complaint handlingand post-market surveillance,regulatory affairs,isostandards,management reviews,training anddevelopment,leadership,auditing,quality assurance,qualitymanagement systems (qms),team leadership,supplier qualitymanagement,quality control,total quality management (tqm),qualityauditing,communication

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