Quality Manager

Position SummaryThe Quality Manager is responsible for the development, implementation, and continuous improvement of the site's Quality Management System (QMS).This role ensures compliance with ISO standards, regulatory requirements, customer expectations, and internal policies.The Quality Manager serves as the primary site representative during external audits (ISO, FDA, RBA, NAID, R2, customer audits) and is accountable for audit readiness at all times.This position holds authority to escalate compliance and quality risks and to stop production or distribution activities when necessary to protect the company and its customers.Key ResponsibilitiesQuality Management System OwnershipMaintain and improve the site's ISO-compliant Quality Management System (ISO 9001, 14001, 45001 and others as applicable)Ensure policies, procedures, and work instructions remain current and controlledOversee document control and revision processesEnsure alignment between documented procedures and operational executionConduct management review preparation and reportingAudit & Regulatory LeadershipLead internal audit program and risk-based audit planningServe as primary host and point of contact for external audits (ISO, FDA, RBA, NAID, R2, customer audits)Coordinate audit logistics, evidence gathering, and response preparationEnsure timely and effective closure of audit findingsMaintain audit readiness year-roundCompliance & Risk ManagementMonitor regulatory and standard changes and update processes accordinglyConduct compliance risk assessments and gap analysesEscalate systemic risks to site leadershipEnsure preventive controls are implemented to avoid repeat findingsQuality Assurance & Quality Control OversightEnsure quality assurance systems are effectively implemented and followedVerify work instructions and inspection controls are adhered to on the floorDrive containment actions for quality issuesLead root cause analysis (5-Why, Fishbone, etc.)Ensure corrective and preventive actions are effective and sustainablePartner with operations to reduce defects and nonconformancesCAPA & Continuous ImprovementOwn CAPA lifecycle from identification through effectiveness verificationTrack corrective action timelines and accountabilityAnalyze quality trends and identify systemic improvement opportunitiesSupport continuous improvement initiatives aligned to SQDIP goalsTraining & AwarenessEnsure required compliance and quality training is completed and documentedProvide guidance and education to supervisors and associates on quality expectationsReinforce the "why" behind compliance and quality requirementsSupport development of a culture of accountability and ethical practicesAuthority & AccountabilityThe Quality Manager has the authority to:Stop production or distribution activities due to quality or compliance riskRequire corrective actions across departmentsEscalate regulatory or customer risk directly to senior leadershipRepresent the site during regulatory and certification auditsThis role operates independently within the organizational structure to ensure objectivity and system integrity.QualificationsRequiredBachelor's degree in Business, Engineering, Quality, Compliance, or related field (or equivalent experience)Minimum 5 years of experience in compliance, quality systems, or regulatory environmentsExperience implementing and maintaining ISO 9001 or similar quality standardsExperience leading internal and external auditsStrong knowledge of CAPA, root cause analysis, and risk mitigation processesExcellent documentation control and analytical skillsStrong communication and cross-functional leadership abilityProficiency in MS Office and quality documentation systemsBilingual (English/Spanish)PreferredExperience in supply chain, manufacturing, or distribution environmentsFamiliarity with RBA, NAID, R2, ISO 14001, ISO 45001Lead Auditor certificationWork EnvironmentPrimarily office-based within a manufacturing and distribution facilityFrequent interaction with production and warehouse areasExposure to operational noise and lift truck trafficPeriodic domestic travel (up to 25%) as required