Quality Assurance Inspector

Quality Assurance InspectorThe Quality Inspector I performs inspection and quality assurance activities in support of manufacturing and quality objectives to ensure products consistently meet customer, regulatory, and internal specifications. This role is responsible for inspecting incoming materials, in-process components, sub-assemblies, and finished medical devices while maintaining accurate documentation and supporting compliance with the Aptyx Quality System.The ideal candidate is detail-oriented, capable of working in a regulated cleanroom environment, and comfortable utilizing metrology equipment and inspection techniques within a fast-paced medical device manufacturing setting.Duties and ResponsibilitiesFollow the Aptyx Quality System, including all applicable SOPs, work instructions, and Training Matrix requirementsInspect incoming materials to verify compliance with purchase order and specification requirementsPrepare and maintain inspection workstations, including organization, cleanliness, and material identificationPerform in-process, sub-assembly, and final product inspections to ensure compliance with customer and internal specificationsConduct first article inspections (FAI) and complete associated inspection reports and documentationAccurately complete inspection records, lot history records (LHRs), forms, and other quality documentation in accordance with applicable proceduresPerform line clearance audits and support production readiness activitiesIdentify, document, and communicate nonconformances or product defects to supervisors, engineers, production leadership, and/or Quality representativesSupport reject log activities and defect tracking processesMaintain identification and traceability of materials, tools, and documentation throughout inspection activitiesPerform lot release testing with guidance or support from higher-level inspectors, engineers, or quality personnel as neededNotify supervision of equipment, tooling, or inspection instrument issues requiring maintenance or repairUtilize metrology equipment including calipers, micrometers, microscopes, vision systems, and other inspection tools to obtain accurate inspection resultsSupport continuous compliance with cleanroom and controlled environment proceduresMaintain positive working relationships with peers, supervisors, and cross-functional teamsWork overtime as required to support production and business needsPerform other duties as assignedEducationHigh School Diploma or GED requiredVocational or technical training preferredExperience2–5 years of inspection or quality experience in a manufacturing environment; medical device industry experience preferredExperience working in a regulated environment preferredBasic computer proficiency required, including experience with data entry and electronic documentation systemsQualifications and SkillsAbility to read, write, verbally communicate, and follow instructions in EnglishAbility to work extended periods under a microscope while maintaining inspection accuracyAbility to work in a cleanroom environment for an entire shift, including wearing required cleanroom garments and PPEStrong attention to detail and defect awarenessAbility to organize and prioritize work efficiently in a fast-paced environmentAbility to read and interpret engineering drawings, specifications, and work instructionsExperience using metrology and inspection equipment including: CalipersMicrometersVision measurement systemsInspection microscopesOther precision measurement instrumentsStrong documentation and data entry skillsFamiliarity with Microsoft Office applications including Word and Excel, as well as Adobe PDF toolsGood hand-eye coordination and manual dexteritySound judgment and decision-making skillsAbility to maintain confidentiality in accordance with company policiesAbility to complete required training and retain knowledge necessary to effectively perform inspection responsibilitiesPhysical Demands and Work EnvironmentThis position primarily works within a controlled environment room (CER), cleanroom, manufacturing, packaging, and warehouse environment.The employee must be able to:Sit, stand, and perform repetitive inspection activities for extended periodsUse hands, fingers, and vision for detailed inspection and measurement tasksWork under a microscope for extended periods of timeWear cleanroom garments including gowns, gloves, head coverings, and shoe covers throughout the shiftLift and move materials up to 25 pounds occasionallyCommunicate effectively verbally and in writingReasonable accommodations may be made to enable individuals with disabilities to perform essential functions.Measurement of PerformanceCompletion of inspections and assigned quality activities accurately and within required timelinesAccuracy and completeness of inspection records, NCRs, first article reports, and related documentationProper and effective use of metrology and inspection equipmentCompliance with written procedures, quality requirements, and cleanroom practicesTimely identification and communication of product defects and nonconformancesPositive collaboration with peers, supervisors, production teams, and internal customersSupport of production quality objectives and continuous improvement initiativesAcknowledgementI have received a copy of this job description, have read and understood it, and will complete all assigned duties and responsibilities. I recognize that the company reserves the right to modify this job description and that I will be informed of any and all modifications prior to their effective date.Employee Signature - Date