Quality Complaints Manager
3 weeks ago
pstrongJobSummary/strong/ppTheManager,QualityComplaintsMDR/MDVisresponsibleforoverseeingthecomplainthandlingprocessrelatedtothedocumentation,investigation,timelyprocessing,andreportingofMedicalDeviceReports(MDR)andMedicalDeviceVigilance(MDV)withemphasisonregulatorycompliance./ppstrongDuties&Responsibilities/strong/pulliManagetheday-to-daycomplainthandlingprocesswithemphasisonMDRandMDVmanagementandrelatedactivities./liliOverseetheinvestigationandreviewprocessrelatedtopost-marketadverseeventreportingfortheUS,Europe,andotherInternationalregulatorybodies./liliEnsureallrequiredmedicaldevicereportsaresubmittedinaccordancewiththeCompany'sprocedures./liliLeadthedevelopmentofpreliminaryhealthhazardevaluationsandreviews,productanalyses,andfailureinvestigations,asrequired./liliCollaboratewithclinicalteamsonhealthhazardevaluationsandreviewofcomplaintswithregardtopatientriskandsafetyassessments./liliProvidetrainingtointernalteammembersontheCompany'scomplainthandlingprocess,MDR,andMDVprocessesandrequirements./liliInterfacewithhospitalriskmanagementpersonnelandphysiciansduringtheprocessofconductinginvestigationsforadverseevents./liliDraftandreviewcustomerresponsesand/orresponsestoglobalregulatorybodies./liliMonitortrendsinareasofresponsibilityandescalateissuestomanagement,asneeded./liliServeasthesubjectmatterexpertforMDRandMDVfunctionsduringinternalandexternalaudits./liliEnsurethatallcomplaintsrelatedtoMDRandMDVrequiringresponsesareproperlyaddressed./liliOverseetheworkofassignedteammembers;coordinateworkschedules;assistmanagementindevelopingstandardsforacceptablelevelsofperformancewithintheworkgroup;monitorandreportonperformanceagainstestablishedstandards;reportonperformanceforthepurposeofidentifyingtraininganddevelopmentopportunitiesforstaff;makehiring,promotion,demotion,andterminationdecisions;makestaffannualperformanceappraisalsandsalaryincreasedecisions;providetechnicalguidanceand/orsubjectmatterexpertiseforstaff;approvehoursworkedandtimeoffrequests./liliResponsibleformonthlyMDRReviewBoardandAccuracymeetings./liliParticipateinmonthlyPost-MarketSurveillancemeetingsandprovidedataasneeded./liliPerformotherdutiesorspecialprojectsasassignedbyareamanagement./li/ulpstrongRequirements/strong/pulli8ormoreyearsofexperienceprocessingcomplaintsinthemedicaldeviceindustry./liliExperiencedinMedWatchandinternationaladverseeventreportingrequirements./liliExperiencedinFDAQualitySystemRegulations-21CFRpart820,Part803,andPart806and,MedicalDeviceDirective,EUMedicalDevicesRegulation,andMEDDEVguidancedocuments,associatedharmonizedstandards,ISO13485,andrelatedqualitystandards./li/ulpstrongSkillsRequired/strong/pulliStrongcomputerskills./liliStrongorganizationalandanalyticalskills./liliAbilitytointeracteffectivelyonateamandwithinternalandexternalcustomers./liliDemonstratedindependentworkerwithabilitytofocus./liliDemonstratedattentiontodetail./li/ulpstrongEducation/strong/pulliBachelor'sDegreeisrequired,preferablywithintheSciencesortheClinicalfield./li/ulpstrongCompensation/strong/ppTheanticipatedrangeforthispositionis$125,000to$150,000.Actualplacementwithintherangeisdependentonmultiplefactors,includingbutnotlimitedtoskills,education,andexperience./ppstrongWorkEnvironment/strong/ppThispositionprimarilyworksinanofficeenvironment.Itrequiresfrequentsitting,standing,andwalking.Dailyuseofacomputerandothercomputinganddigitaldevicesisrequired.Maystandforextendedperiodswhenfacilitatingmeetingsorwalkinginthefacilities.Somelocaltravelisnecessary,sotheabilitytooperateamotorvehicleandmaintainavalidDriver'slicenseisrequired./ppThephysicaldemandsofthepositiondescribedhereinareessentialfunctionsofthejobandemployeesmustbeabletosuccessfullyperformthesetasksforextendedperiods.Reasonableaccommodationsmaybemadeforthoseindividualswithrealorperceiveddisabilitiestoperformtheessentialfunctionsofthejobdescribed./p
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Quality Complaints Manager
4 weeks ago
Irvine, California, United States Masimo Full timeJob Title: Quality Complaints ManagerAt Masimo, we are seeking a highly skilled Quality Complaints Manager to join our team. As a key member of our Quality team, you will be responsible for managing the complaint handling process related to medical device reports (MDRs) and medical device vigilance (MDVs).Key Responsibilities:Manage the day-to-day complaint...
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Medical Device Complaints Manager
3 weeks ago
Irvine, California, United States Masimo Full timeJob Title: Medical Device Complaints ManagerJob Summary: We are seeking a highly skilled Medical Device Complaints Manager to join our team at Masimo. The successful candidate will be responsible for managing the complaint handling process related to the documentation, investigation, and timely processing of Medical Device Reports (MDR) and Medical Device...
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Quality Assurance Manager
4 weeks ago
Irvine, California, United States Youtheory Full timeJob Title: Quality Control ManagerJoin Nutrawise Health & Beauty, a leading manufacturer of health and wellness supplements, in Irvine, California. As a Quality Control Manager, you will play a crucial role in ensuring the quality and safety of our products.Job Summary:We are seeking a highly skilled and experienced Quality Control Manager to join our team....
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THV Quality Assurance Specialist
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Irvine, California, United States Entegee Full timeJob OverviewWe are seeking a highly skilled THV Quality Assurance Specialist to join our team. The ideal candidate will have a strong background in quality assurance and compliance, with experience in medical device testing and investigation.The successful candidate will be responsible for investigating product quality issues, performing device testing, and...
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Senior Director of Quality Systems
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Quality Manager
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Irvine, California, United States Graphic Packaging International Full timeJob Summary:The Quality Technician will be responsible for ensuring the quality of all folding carton products and related raw materials during the sheeting, printing, cutting, folding, gluing, and packaging processes. This includes administering quality standards, inspecting department samples, collecting QC samples, and maintaining the Quality Sample...
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Quality Manager
4 weeks ago
Irvine, California, United States Integra LifeSciences Full timeJob Title: Quality ManagerIntegra LifeSciences is seeking a highly skilled Quality Manager to lead our Irvine Quality functions. As a key member of our team, you will be responsible for developing a best-in-class quality team and ensuring the organizational talent and resources are aligned with key business imperatives.Key Responsibilities:Provide leadership...
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3 weeks ago
Irvine, California, United States Integra LifeSciences Full timeQuality Assurance SpecialistAt Integra LifeSciences, we are committed to delivering high-quality products that meet the needs of our customers. As a Quality Assurance Specialist, you will play a critical role in ensuring that our products meet the highest standards of quality and safety.Key Responsibilities:Lead critical Supplier Quality related projects and...
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4 weeks ago
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Quality Assurance Manager
4 weeks ago
Irvine, California, United States W3Global Inc Full timeJob Title: Quality Control ManagerAt W3Global Inc, we are seeking a highly skilled Quality Control Manager to lead our quality control program and ensure that our products meet established quality standards.Key Responsibilities:Develop and implement quality control processes to ensure product quality and customer satisfaction.Lead and manage a team of...
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Quality Assurance Manager
4 weeks ago
Irvine, California, United States Staffosaurus Full timeAbout the JobWe are seeking a highly skilled Quality Assurance Manager to oversee our Quality Management System. The ideal candidate will have a strong background in quality assurance and a proven track record of ensuring compliance with regulatory requirements.Key ResponsibilitiesOversee the Quality Management System to ensure compliance with regulatory...
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Senior Quality Assurance Engineer
4 weeks ago
Irvine, California, United States Glidewell Full timeJob Title: Senior Quality Assurance EngineerGlidewell Laboratories is seeking a highly skilled Senior Quality Assurance Engineer to join our team. As a key member of our quality team, you will be responsible for leading the implementation of our Software Quality Management System (QMS) in conformance with US FDA Quality System Regulations and ISO 13485...
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Quality Assurance Manager
4 weeks ago
Irvine, California, United States CG ONCOLOGY INC Full timeJoin Our Team at CG Oncology Inc.We are seeking a highly skilled and experienced Quality Assurance Manager to join our team at CG Oncology Inc. As a key member of our commercial quality assurance team, you will play a critical role in ensuring the quality and compliance of our pharmaceutical products.Key Responsibilities:Develop and implement quality...
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Quality Control Manager
4 weeks ago
Irvine, California, United States Youtheory Full timeJob SummaryNutrawise Health & Beauty is seeking a highly skilled Quality Control Manager to join our team in Irvine, California. As a key member of our Quality Assurance department, you will be responsible for ensuring the quality and compliance of our products.Key ResponsibilitiesManage the QC laboratory and ensure compliance with SOPs and GMPsDevelop and...
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Quality Assurance Manager
4 weeks ago
Irvine, California, United States Youtheory Full timeJob SummaryNutrawise Health & Beauty, a leading manufacturer of health and wellness supplements, is seeking a highly skilled Quality Control Manager to join its Irvine, California-based team. As a key member of the Quality Assurance department, you will be responsible for ensuring the quality and compliance of our products, from raw materials to finished...
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Quality Assurance Specialist
3 weeks ago
Irvine, California, United States Aequor Technologies Full timeThe Quality Assurance Specialist at Aequor Technologies is responsible for ensuring the quality and control of manufacturing processes and post-market performance of medical devices.Key responsibilities include collaborating with internal and external stakeholders to achieve company objectives, leading technical root cause investigations, developing and...
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Senior Quality Assurance Engineer
4 weeks ago
Irvine, California, United States Integra LifeSciences Full timeJob SummaryWe are seeking a highly skilled Senior Quality Assurance Engineer to join our team at Integra LifeSciences. As a key member of our quality team, you will be responsible for leading critical supplier quality-related projects and issues, including supplier visits and audits.Key Responsibilities:Provide support to sites by leading critical supplier...