Quality Control Manager

Quality Control ManagerA well-established medical device contract manufacturer operating in a regulated environment is seeking an experienced Quality Control Manager to lead their QC function. This is a full-time, onsite position based in Gardner, MA — no hybrid or remote options are available.Position OverviewThe Quality Control Manager is responsible for leading and maintaining all quality control activities within a predominantly Class II medical device contract manufacturing environment. This role ensures compliance with FDA regulations, ISO 13485, and customer-specific requirements across the full spectrum of QC operations — including metrology and calibration, incoming inspection, in-process and final product acceptance, DHR review, nonconforming material management, and team leadership. The ideal candidate brings deep technical knowledge of medical device inspection methodologies and metrology, combined with proven supervisory experience and the ability to collaborate cross-functionally with Manufacturing, Engineering, Supply Chain, Regulatory Affairs, and Quality Assurance.Key ResponsibilitiesQuality Control OperationsManage daily QC operations to ensure timely inspection, testing, review, and release of materials and finished devicesEstablish priorities and allocate resources to meet production schedules while maintaining full complianceDevelop, implement, and maintain QC procedures, work instructions, inspection methods, and acceptance criteriaEnsure all QC activities are performed per approved procedures and appropriately documentedIncoming InspectionOversee receipt inspection programs for components, raw materials, labels, packaging, and outsourced servicesReview and disposition incoming inspection results and supporting supplier documentationSupport supplier quality activities, performance monitoring, and corrective action processesEnsure risk-based inspection methodologies are effectively implementedFinal Product Testing & ReleaseManage final inspection and product acceptance activitiesEnsure all device testing is performed per validated methods and approved specificationsReview quality records supporting final product acceptanceAuthorize or oversee final release of finished medical devices prior to shipmentDevice History Record (DHR) ReviewPerform or oversee comprehensive DHR reviews for completeness, accuracy, and traceabilityEnsure all required documentation, signatures, and approvals are in place before product releaseIdentify documentation deficiencies and coordinate corrections with relevant departmentsCalibration & MetrologyAdminister and continuously improve the calibration program for all inspection, measuring, and test equipmentEnsure calibration activities are performed within established intervals and traceable to recognized standardsInvestigate and assess the impact of out-of-tolerance equipment findingsCoordinate external calibration vendors and manage equipment qualification and maintenanceApply metrology principles to measurement system development and quality control processesMaintain familiarity with Gage R&R and measurement system analysis methodologiesNonconforming Product ManagementIdentify, document, segregate, and control nonconforming materials and productsParticipate in MRB activities and support CAPA, complaint, and audit-related investigationsIssue SCARs and manage return-to-vendor processes as appropriateTeam LeadershipLead, coach, mentor, and develop a team of 4–5 Quality Control Inspectors and TechniciansConduct training, qualification, and competency assessmentsEstablish departmental goals, performance metrics, and support employee developmentPromote a culture of quality, compliance, accountability, and continuous improvementQuality Systems & Continuous ImprovementSupport internal, customer, and supplier audits as well as regulatory inspectionsParticipate in CAPA investigations and effectiveness verificationAssist with process validation, equipment qualification, and manufacturing improvement initiativesAnalyze quality performance metrics and identify trends and opportunities for improvementParticipate in Management Review and QMS improvement activitiesQualificationsRequired:Bachelor's degree in Engineering, Quality, Life Sciences, Manufacturing, or a related technical discipline (equivalent experience considered)5+ years of QC, QA, or manufacturing quality experience in the medical device industry2–3+ years of supervisory or leadership experience with direct reportsDemonstrated experience in metrology and calibration management — this is a critical requirement for the roleHands-on experience with incoming inspection, final product release, DHR review, nonconforming material disposition, CAPA participation, and internal/external auditsClass II medical device experience or higher requiredStrong knowledge of FDA 21 CFR Part 820 and ISO 13485Ability to read and interpret engineering drawings, dimensions, and specificationsKnowledge of statistical sampling plans, inspection techniques, and risk management principles (ISO 14971)Strong technical writing, documentation, and communication skillsExperience using ERP, electronic QMS, and calibration management systemsPreferred:ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or Certified Quality Technician (CQT)ISO 13485 Lead Auditor certificationExperience with electronic and paper-based DHR systemsBackground in IQ/OQ/PQ validation activitiesContract manufacturing environment experiencePhysical RequirementsAbility to work in manufacturing and cleanroom environmentsAbility to perform visual inspectionsOccasional lifting up to 25 lbs.Ability to stand or sit for extended periods as neededEqual Opportunity StatementThis employer is committed to building a diverse and inclusive workplace. All qualified applicants will be considered without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other characteristic protected under applicable federal, state, or local law.