Keller Executive Search is partnering with a leading manufacturing organization to appoint an experienced Quality Systems and Risk Management Manager This is a pivotal role for a quality professional who thrives at the intersection of systems governance regulatory compliance and proactive risk management and who wants to make a measurable impact on product quality and operational excellenceReporting into senior leadership you will own the design maintenance and continuous improvement of the quality management system while leading a structured approach to risk identification mitigation and control across the product lifecycle You will work crossfunctionally with operations engineering supply chain and external partners to ensure that quality standards regulatory requirements and customer expectations are consistently metThis is an excellent opportunity for someone ready to shape quality strategy strengthen audit readiness and embed a culture of continuous improvement Our client values rigor collaboration and forwardthinking problem solving and offers a stable growthoriented environment where quality leadership is genuinely valuedKey ResponsibilitiesOwn maintain and continuously improve the quality management system to ensure ongoing compliance with applicable standards and regulationsLead the organizations risk management program including risk assessments mitigation planning and corrective and preventive actions CAPAPlan conduct and coordinate internal and external audits and manage responses to regulatory and customer auditsDevelop review and control quality documentation procedures and records to support audit readinessManage supplier and contractmanufacturer quality including qualification monitoring and periodic onsite assessmentsAnalyze quality data and trends to drive rootcause investigations and measurable improvementsPartner with operations engineering and supply chain to embed quality and risk controls across the product lifecycleLead mentor and develop quality staff and champion a culture of continuous improvementPrepare and present quality and risk metrics and reports to senior managementAdditional InformationLocation United States specific site details shared later in the processWorking pattern primarily onsite with occasional remote flexibility based on business needsRequirementsEssentialBachelors degree in engineering quality life sciences or a related technical field5 years of experience in quality systems quality assurance or quality management within a manufacturing or regulated environmentWorking knowledge of ISO 13485 FDA Quality System requirements and ISO 14971 risk management principlesPractical knowledge of risk management methodologies and CAPA processesExperience planning and conducting internal and external auditsStrong analytical documentation and problemsolving skillsAbility to work onsite as the primary work locationPreferredProfessional certification such as CQE CQM CQA Six Sigma or Lead AuditorExperience with regulated or highly controlled manufacturing environmentsPrior peoplemanagement or team leadership experienceExperience managing supplier or contractmanufacturer qualityExperience with electronic quality management systemsIdeal Candidate ProfileYou are a detaildriven yet strategically minded quality leader who balances compliance discipline with practical continuousimprovement thinking You communicate clearly across functions influence without authority and stay calm and organized during audits You take ownership of quality outcomes and enjoy building robust systems that scaleBenefitsRelocation support is available for candidates who are not local this can be structured as coverage of relocation costs or as a flat signon bonus to help the successful candidate make the moveThis is primarily an onsite role with limited flexibility for occasional remote work based on business needs and responsibilitiesOnly limited travel is expected typically a few trips per year for supplier or contractmanufacturer visits audits or industry events site visits can be covered by other team members where travel is not feasibleKeller is a recruitment agency that provides services to clients ranging from startups and non profits to multinational corporations Keller emphasizes ethical search processes attentive candidate care and leadership placements that support longterm client outcomesTo learn more about the firm and about our candidate services please visit our websiteEqual Employment Opportunity and NonDiscrimination PolicyEqual Employment Opportunity Statement Both Keller Executive Search and our clients are Equal Opportunity Employers For all positions whether with Keller Executive Search or our clients qualified applicants will receive consideration for employment without regard to race skin color religion sex sexual orientation gender identity gender expression national origin age protected veteran status disability genetic information or any other legally protected statusCommitment to
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