Analytical Laboratory Manager – Medical Devices

The Analytical Laboratory Manager is responsible for leading and maintaining a compliant analytical laboratory that supports medical device manufacturing, product release, validation, and laboratory investigations. This role ensures laboratory operations meet FDA Quality Management System Regulation (21 CFR Part 820), ISO 13485:2016, and applicable international regulatory requirements. The manager provides technical and people leadership, ensures data integrity, and drives continuous improvement while maintaining inspection readiness at all times.Key ResponsibilitiesLaboratory Leadership & OperationsLead day‑to‑day analytical laboratory operations supporting incoming inspection, in‑process controls, final product release, validation, and complaint investigationsEnsure analytical testing is accurate, timely, and aligned with product and regulatory requirementsReview and approve analytical test results, reports, and data packages prior to product dispositionEstablish priorities and resource allocation to support production and quality needsRegulatory Compliance & Quality SystemsEnsure laboratory compliance with FDA QMSR (21 CFR 820), ISO 13485, and applicable ISO testing standardsAuthor, review, approve, and maintain laboratory SOPs, work instructions, test methods, and validation protocolsMaintain inspection readiness and support FDA, notified body, customer, and internal auditsLead or support laboratory investigations, including OOS/OOT, nonconformances, deviations, CAPAs, and change controlsEnsure ALCOA+ data integrity principles are implemented and sustained within the laboratoryAnalytical Methods & EquipmentOversee development, validation, verification, and lifecycle management of analytical methodsEnsure laboratory equipment is properly qualified, calibrated, maintained, and documentedManage equipment obsolescence, upgrades, and new technology introductionEvaluate and select external test laboratories when internal testing is not availablePeople Management & DevelopmentDirectly manage laboratory analysts, technicians, and/or supervisorsEnsure personnel training, qualification, and competency assessments are completed and maintainedMentor staff on technical skills, GMP compliance, documentation, and root cause analysisPromote a culture of accountability, quality, and continuous improvementSafety & Environmental ComplianceEnsure laboratory compliance with EHS requirements, chemical hygiene plans, and waste disposal regulationsPromote safe laboratory practices and respond to safety incidents or near missesContinuous Improvement & Cross‑Functional SupportDrive continuous improvement initiatives to enhance laboratory efficiency, compliance, and cost effectivenessPartner with Manufacturing, Engineering, Supplier Quality, R&D, and Regulatory Affairs to resolve quality and technical issuesSupport process validation, design verification/validation (DV/PV), and technology transfersRequired QualificationsBachelor’s degree in Chemistry, Analytical Chemistry, Materials Science, Engineering, or related scientific disciplineMinimum 5–7 years of analytical laboratory experience in a regulated medical device or life sciences environmentAt least 2 years of people leadership or technical leadership experienceStrong working knowledge of analytical techniques such as HPLC, GC, FTIR, UV‑Vis and wet chemistrySolid understanding of FDA QSR, ISO 13485, and medical device quality systems