Quality Assurance Specialist

Position SummaryThe Quality Assurance (QA) Specialist is responsible for ensuring that provisioning, configuration, and kitting of medical devices (mobile phones, tablets, and related equipment) meet all applicable regulatory, quality, and customer requirements.This role supports production operations by enforcing quality systems, maintaining compliance with medical device regulations, and driving continuous improvement initiatives through root cause analysis, CAPA processes, risk management, and rigorous documentation practices.Key ResponsibilitiesQuality OversightMonitor provisioning, configuration, and kitting operations on the production floor.Perform in-process and final inspections to ensure compliance with specifications and quality standards.Ensure proper handling, labeling, and traceability of serialized devices and kit components.Regulatory Compliance (Medical Devices)Ensure compliance with applicable regulatory standards, including:ISO 13485 – Medical Device Quality Management SystemsISO 9001 – Quality Management SystemsFDA 21 CFR Part 820 – Quality System Regulation (QSR)21 CFR Part 11 – Electronic Records and Signatures (as applicable)HIPAA – Protection of patient data / PHIAdditional responsibilities include:Maintaining audit readiness.Supporting internal, customer, and regulatory audits.Ensuring compliance with established quality management systems and operational procedures.Documentation & Medical Device ReportingCreate, review, and maintain:Device History Records (DHRs)Device Master Records (DMRs)Batch and lot recordsGenerate and manage quality system documentation, including:Non-Conformance Reports (NCRs)Deviation reportsAudit findings and corrective action reportsAdditional responsibilities:Ensure full traceability of serialized devices, IMEI tracking, and asset management throughout provisioning and kitting processes.Support and maintain Production Part Approval Process (PPAP) documentation, including:Control PlansProcess Flow DiagramsInspection & Test ResultsFirst Article Inspections (FAI), where applicableReview, validate, and maintain Certificates of Compliance (CoC) and supplier quality documentation.Ensure incoming materials and components meet specification and regulatory requirements.Collaborate with suppliers and internal teams to resolve documentation discrepancies and quality issues.Risk ManagementParticipate in risk analysis activities aligned with ISO 14971 standards.Support development and maintenance of:Risk assessments (FMEA – Failure Mode and Effects Analysis)Risk control and mitigation plansEnsure risks are properly documented, monitored, and updated throughout the product lifecycle.Process Quality Control & ValidationIdentify process deviations and implement corrective actions.Support validation and qualification activities for provisioning systems, software, and operational processes.Ensure all processes meet regulatory validation and documentation requirements.Data Integrity & ComplianceEnsure integrity, accuracy, and security of provisioning data.Verify compliance with HIPAA and data handling policies when managing sensitive information.Continuous ImprovementAnalyze quality metrics and trends to identify improvement opportunities.Support Lean and Six Sigma initiatives to improve process performance and compliance.Drive enhancements in quality systems and operational efficiency.Training & Production SupportTrain production personnel on quality standards, SOPs, and regulatory requirements.Serve as a quality representative on the production floor.Promote a culture of quality awareness and compliance throughout operations.Required QualificationsBachelor’s degree in Quality, Engineering, Life Sciences, or a related field (or equivalent combination of education and experience).Minimum of 2 years of Quality Assurance experience in:Medical device manufacturing (preferred), orOther highly regulated manufacturing environmentsHands-on experience with:Root Cause Analysis (RCA)CAPA systems and processesQuality documentation and reportingPreferred QualificationsStrong experience with:ISO 13485 (highly preferred)FDA 21 CFR Part 820Experience with:PPAP documentationSupplier quality managementHIPAA complianceSoftware/system validation conceptsExperience using electronic Quality Management Systems (eQMS), including:CAPA managementDeviationsAudit trackingKey Skills & CompetenciesStrong analytical and problem-solving skillsKnowledge of medical device regulations and compliance frameworksExperience with PPAP, CoC, and supplier quality controlsExcellent documentation and reporting capabilitiesStrong attention to detail and data integrityEffective cross-functional communication and collaboration skillsAdditional RequirementsExperience supporting regulatory audits and inspectionsAbility to work with sensitive medical/device data in compliance with HIPAA requirementsFamiliarity with traceability systems and serialized inventory managementAbility to work on the production floor as neededNice-to-Have / Bonus SkillsLean / Six Sigma certificationExperience with ERP and MES systemsExperience in medical device kitting, logistics, or provisioning operations