Quality Control Laboratory Manager

Job Title: Quality Control Laboratory ManagerLocation: Chicago, ILDuration: 12 Months (Possible for extention)About the Role: Our client is seeking an QC Laboratory Manager to lead a compliant analytical laboratory supporting medical device manufacturing, product release, validation, and investigations. This role requires strong technical expertise, leadership capabilities, and a deep understanding of regulatory standards to ensure consistent inspection readiness and data integrity.Key Responsibilities:Lead day-to-day analytical laboratory operations including incoming inspection, in-process testing, final release, validation, and complaint investigationsEnsure accurate, timely, and compliant analytical testing aligned with regulatory and product requirementsReview and approve test results, reports, and data packages prior to product dispositionManage lab priorities, resources, and workflow to support production and quality objectivesEnsure compliance with FDA QMSR (21 CFR Part 820), ISO 13485, and applicable standardsAuthor, review, and maintain SOPs, test methods, and validation protocolsMaintain audit readiness and support FDA, notified body, and internal auditsLead investigations (OOS/OOT, deviations, CAPAs, nonconformances, change controls)Ensure implementation of ALCOA+ data integrity principlesOversee method development, validation, and lifecycle managementManage laboratory equipment qualification, calibration, maintenance, and upgradesEvaluate and manage external testing laboratories as neededLead, mentor, and develop laboratory staff; ensure training and competency compliancePromote a culture of quality, safety, and continuous improvementEnsure compliance with EHS standards, chemical safety, and waste managementCollaborate with Manufacturing, Engineering, Quality, R&D, and Regulatory teamsSupport validation activities (process validation, DV/PV) and technology transfersRequired Qualifications:Bachelor’s degree in Chemistry, Analytical Chemistry, Materials Science, Engineering, or related field5–7+ years of analytical laboratory experience in a regulated medical device or life sciences environment2+ years of leadership (people or technical leadership) experienceStrong experience with analytical techniques such as HPLC, GC, FTIR, UV-Vis, and wet chemistrySolid understanding of FDA QSR (21 CFR Part 820), ISO 13485, and quality systemsStrong problem-solving, documentation, and communication skillsPreferred Qualifications:Master’s degree in a scientific or engineering disciplineExperience supporting regulatory inspections (FDA, notified bodies)Experience with LIMS systemsLean, Six Sigma, or formal root cause analysis trainingIf you are open to exploring other opportunities within the Life Sciences industry, please feel free to share your resume at eswar@intellectt.com