Laboratory Manager

Job Title: Laboratory ManagerLocation: Arlington Heights, ILShift: M-FPay: $130k-$145k Salary (+Bonus)Hire Type: Direct-Hire (Full-time)Position SummaryThe Analytical Laboratory Manager is responsible for leading and maintaining a compliant analytical laboratory that supports medical device manufacturing, product release, validation, and investigations. This role ensures laboratory operations meet FDA Quality System Regulation (21 CFR Part 820), ISO 13485:2016, and applicable global regulatory requirements.The manager provides both technical and people leadership, ensures data integrity, and drives continuous improvement while maintaining a constant state of inspection readiness.Key ResponsibilitiesLaboratory Leadership & OperationsLead daily analytical laboratory operations supporting incoming inspection, in-process controls, final product release, validation, and complaint investigationsEnsure testing is accurate, timely, and aligned with product specifications and regulatory requirementsReview and approve analytical data, reports, and test results prior to product dispositionEstablish priorities and allocate resources to meet production and quality objectivesRegulatory Compliance & Quality SystemsEnsure compliance with FDA QSR (21 CFR Part 820), ISO 13485, and applicable ISO testing standardsAuthor, review, and approve SOPs, work instructions, test methods, and validation protocolsMaintain inspection readiness and support FDA, notified body, customer, and internal auditsLead or support investigations, including OOS/OOT, nonconformances, deviations, CAPAs, and change controlsEnsure adherence to ALCOA+ data integrity principles across all laboratory activitiesAnalytical Methods & EquipmentOversee development, validation, verification, and lifecycle management of analytical methodsEnsure laboratory equipment is qualified, calibrated, maintained, and properly documentedManage equipment lifecycle, including obsolescence, upgrades, and new technology implementationEvaluate and manage external testing laboratories when neededPeople Leadership & DevelopmentLead, coach, and develop laboratory analysts, technicians, and supervisorsEnsure training, qualification, and competency assessments are completed and maintainedMentor team members on technical skills, GMP compliance, documentation practices, and root cause analysisFoster a culture of accountability, quality, and continuous improvementSafety & Environmental ComplianceEnsure compliance with EHS requirements, including chemical hygiene and waste disposal regulationsPromote safe laboratory practices and respond to safety incidents or near missesContinuous Improvement & Cross-Functional CollaborationDrive initiatives to improve laboratory efficiency, compliance, and cost effectivenessPartner with Manufacturing, Engineering, Supplier Quality, R&D, and Regulatory Affairs to resolve technical and quality issuesSupport process validation, design verification/validation (DV/PV), and technology transfersQualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or genetic information.