{"schemaVersion":"jobsearcher.job.v1","id":"cd037ef4eae89c1eaf107258","url":"https://jobsearcher.com/jobs/cd037ef4eae89c1eaf107258","canonicalUrl":"https://jobsearcher.com/jobs/cd037ef4eae89c1eaf107258","title":"Quality Manager","description":"ABOUT HARVARD BIOSCIENCE\nHarvard Bioscience is a leading global developer, manufacturer and seller of technologies, products and services that enable fundamental research, discovery, and pre-clinical testing for drug development. Our customers range from renowned academic institutions and government laboratories, to the world's leading pharmaceutical, biotechnology and clinical research organizations.\nPOSITION SUMMARY\nHarvard Bioscience is looking for a Quality Manager for our New Brighton office. This role is responsible for executing the Global Quality Plan, driving cultural changes toward Quality processes, and collaborating with production, product development, sales/marketing, and post-market teams to ensure connection with processes and data.\nESSENTIAL DUTIES AND RESPONSIBILITIES\nLeadership:\nSupport and expand the culture to provide high quality products to customers.\nProvide mentorship to quality team and department leads.\nCultivate collaborative culture across the organization.\nManage the Quality Management System architecture to meet corporate needs.\nReviews Quality System operation and identifies improvements.\nPlans and leads improvement projects.\nQuality:\nLeads execution of the Global Quality Plan in Holliston.\nTracks regulatory changes and makes recommendations for system changes.\nLeads the CAPA review board, including field risk assessment.\nPlans and executes Internal Audit schedule.\nResponds to external information requests (customers, audits).\nProvides perspective and experience for information management procedures and tools.\nOperations:\nSupports validation of manufacturing processes.\nSupports manufacturing change control projects.\nReviews exception proposals as part of risk assessment.\nDesign:\nSupports project, verification, and design validation planning.\nSupports design change control projects.\n\nSKILLS AND ABILITIES REQUIRED\nStrong organization, communication, and leadership skills.\nKnowledge of relevant manufacturing and process development principles and practices.\nProject management skills, ability to plan, and perform against plan.\nInterpersonal and leadership skills with the ability to establish rapport with cross functional team members to create high performance teams.\nConfidence to provide quality staff direction and assignments consistent with department objectives and priorities.\nAbility to review the manufacturing processes, design verification plans and reports, and process validation/qualification protocols and reports.\nFull understanding of ISO 9001:2015 Required.\nExperience with ISO 13485:2016, ISO 14971:2019, IEC 62366-2:2015 or other regulations a plus.\nWilling to share knowledge and teach others about processes.\nKnowledge of the full product lifecycle (Launch/Maintain/Obsolete).\nAbility to work effectively in a cross-functional team environment.\nStrong analytical ability with active listening skills.\nAbility to interpret and articulate regulatory requirements.\nAbility to lead by example.\nEDUCATIONAL REQUIREMENTS AND/OR EQUIVALENT\n4-year engineering degree with 5+ years relevant experience and 2+ years of management experience preferred.\n\nAN EQUAL EMPLOYMENT OPPORTUNITY EMPLOYER/VETERAN/DISABILITY\nFLSA: Exempt\nADA DISCLAIMER\nIn developing this job description care was taken to include all competencies needed to successfully perform in this position. However, for Americans with Disabilities Act (ADA) purposes, the essential functions of the job may or may not have been described for purposes of ADA reasonable accommodation. All reasonable accommodation requests will be reviewed and evaluated on a case-by-case basis.","company":"Harvard Bioscience","rawCompany":"harvard bioscience","city":"St Paul","state":"MN","isRemote":false,"isActive":false,"createdAt":"2026-07-27T11:48:46.808Z","occupations":[{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"},{"code":"11-9121.00","title":"Natural Sciences Managers","slug":"natural-sciences-managers"},{"code":"11-3051.00","title":"Industrial Production Managers","slug":"industrial-production-managers"}],"industries":[{"code":"325414","title":"Biological Product (except Diagnostic) Manufacturing","slug":"biological-product-except-diagnostic-manufacturing"},{"code":"541714","title":"Research and Development in Biotechnology (except Nanobiotechnology)","slug":"research-and-development-in-biotechnology-except-nanobiotechnology"},{"code":"325413","title":"In-Vitro Diagnostic Substance Manufacturing","slug":"in-vitro-diagnostic-substance-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Quality Manager","description":"ABOUT HARVARD BIOSCIENCE\nHarvard Bioscience is a leading global developer, manufacturer and seller of technologies, products and services that enable fundamental research, discovery, and pre-clinical testing for drug development. Our customers range from renowned academic institutions and government laboratories, to the world's leading pharmaceutical, biotechnology and clinical research organizations.\nPOSITION SUMMARY\nHarvard Bioscience is looking for a Quality Manager for our New Brighton office. This role is responsible for executing the Global Quality Plan, driving cultural changes toward Quality processes, and collaborating with production, product development, sales/marketing, and post-market teams to ensure connection with processes and data.\nESSENTIAL DUTIES AND RESPONSIBILITIES\nLeadership:\nSupport and expand the culture to provide high quality products to customers.\nProvide mentorship to quality team and department leads.\nCultivate collaborative culture across the organization.\nManage the Quality Management System architecture to meet corporate needs.\nReviews Quality System operation and identifies improvements.\nPlans and leads improvement projects.\nQuality:\nLeads execution of the Global Quality Plan in Holliston.\nTracks regulatory changes and makes recommendations for system changes.\nLeads the CAPA review board, including field risk assessment.\nPlans and executes Internal Audit schedule.\nResponds to external information requests (customers, audits).\nProvides perspective and experience for information management procedures and tools.\nOperations:\nSupports validation of manufacturing processes.\nSupports manufacturing change control projects.\nReviews exception proposals as part of risk assessment.\nDesign:\nSupports project, verification, and design validation planning.\nSupports design change control projects.\n\nSKILLS AND ABILITIES REQUIRED\nStrong organization, communication, and leadership skills.\nKnowledge of relevant manufacturing and process development principles and practices.\nProject management skills, ability to plan, and perform against plan.\nInterpersonal and leadership skills with the ability to establish rapport with cross functional team members to create high performance teams.\nConfidence to provide quality staff direction and assignments consistent with department objectives and priorities.\nAbility to review the manufacturing processes, design verification plans and reports, and process validation/qualification protocols and reports.\nFull understanding of ISO 9001:2015 Required.\nExperience with ISO 13485:2016, ISO 14971:2019, IEC 62366-2:2015 or other regulations a plus.\nWilling to share knowledge and teach others about processes.\nKnowledge of the full product lifecycle (Launch/Maintain/Obsolete).\nAbility to work effectively in a cross-functional team environment.\nStrong analytical ability with active listening skills.\nAbility to interpret and articulate regulatory requirements.\nAbility to lead by example.\nEDUCATIONAL REQUIREMENTS AND/OR EQUIVALENT\n4-year engineering degree with 5+ years relevant experience and 2+ years of management experience preferred.\n\nAN EQUAL EMPLOYMENT OPPORTUNITY EMPLOYER/VETERAN/DISABILITY\nFLSA: Exempt\nADA DISCLAIMER\nIn developing this job description care was taken to include all competencies needed to successfully perform in this position. However, for Americans with Disabilities Act (ADA) purposes, the essential functions of the job may or may not have been described for purposes of ADA reasonable accommodation. All reasonable accommodation requests will be reviewed and evaluated on a case-by-case basis.","datePosted":"2026-07-27T11:48:46.808Z","dateModified":"2026-07-27T11:48:46.808Z","hiringOrganization":{"@type":"Organization","name":"Harvard Bioscience","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"St Paul","addressRegion":"MN","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"cd037ef4eae89c1eaf107258"},"url":"https://jobsearcher.com/jobs/cd037ef4eae89c1eaf107258"}}