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Senior Quality Specialist

Company: Baebies Inc.
Location: Durham
Posted on: January 16, 2022

Job Description:

Job purposeThe Senior Quality Specialist will be responsible for ensuring compliance with FDA, IVDD, IVDR and ISO 13485 regulations through implementation and maintenance of quality management system design and improvement activities to assure product quality and safety.Senior Quality Specialist: Duties and responsibilitiesEnsure FDA, IVDD, IVDR, ISO 13485 complianceConduct internal audits and manage external auditsAssist in the management of the corrective and preventive action system, initiate, track, close, review and maintain logs and metricsAdministration of non-conforming material and deviation processesSupport document control administration, including review and routing of change orders, filing records, and training need employee on the use of Unipoint and Arena systems.Pre-Market Quality Assurance (Design and Process Documentation Review)Provide support for equipment and process validationManage risk management process throughout product life cycleCompile, analyze, trend and present QMS metricsGather and prepare data for quality meetings and management review meetingsWork closely with Regulatory to ensure labeling meets international regulatory requirements.

Qualifications for Senior Quality SpecialistEducationBS in engineering, life science field, or equivalent experienceExperience:7+ years' experience in Quality Assurance in the medical device industry5+ years' experience with FDA and ISO 13485 quality systems regulations and guidelines.Performance of Internal auditsProduct and process related validationDesign and development process and DHF requirementsSoftware validation activities for medical devicesExperience in small to medium size medical company is preferred.Skill/abilities:Strong statistical data analysis knowledgeRead, interpret, understand, and implement regulations and regulatory requirementsTechnical writing, including reports, and protocolsExcellent verbal and written communication skillsAbility work with all levels of an organizationProject managementWork independently with minimal supervisionWorking conditions: General Office EnvironmentPhysical requirements: Ability to lift up to 20 poundsPI158676017

Keywords: Baebies Inc., Durham , Senior Quality Specialist, Other , Durham, North Carolina

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