633 quality systems specialist jobs at 428 companies in United States
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Quality Systems Specialist
Carrollton, Texas, United States
HybridFull Time
CencoraNYSE: COR: Global pharmaceutical solutions and distribution organization.
2+ YOEBachelor's degree or equivalent experience, 2+ years in quality roles, SOP and CAPA experience, and knowledge of GxP, Quality System Regulations, or ISO standards.
Electronic Quality Management System (eQMS), Microsoft Outlook, Microsoft PowerPoint, Microsoft Word, Microsoft Excel, Microsoft Visio, Adobe Acrobat
Avid Bioservices: A dedicated biologics contract development and manufacturing organization (CDMO) providing development and manufacturing services for pharmaceutical and biotechnology companies.
2+ YOEBachelor’s degree in life sciences or equivalent industry experience, 2–4 years of quality assurance experience, cGMP knowledge, quality standards interpretation, critical thinking, technical writing, and quality systems experience.
ELITechGroup: ELITechGroup is a private in-vitro diagnostics manufacturer serving hospitals and laboratories with instruments, reagents, and software.
3+ YOEBachelor's degree in life science or engineering plus 3 years of manufacturing quality experience, or 5 years of quality or regulatory experience. Metrology certification, quality systems, auditing, CAPA, and eQMS experience required or preferred.
electronic Quality Management System (eQMS), Microsoft Excel, NCR, CAPA, ISO 13485, FDA 21 CFR 820
Actus Nutrition: U.S.-based manufacturer of human and animal nutrition ingredients serving food, beverage, sports-nutrition, pet, and livestock brands.
1+ YOEAssociate's degree required, bachelor's preferred; 1–3 years in quality assurance or quality systems support; working knowledge of FDA nutrition and standards of identity regulations.
FONA InternationalNYSE: MKC: Global leader in herbs, spices, seasonings, and condiments.
Bachelor's degree required; expertise in food safety and quality systems, HACCP, microbiological and allergen monitoring, internal auditing, root cause analysis, and regulatory compliance.
Element Science: Medical device developing wearable cardioverter defibrillators for high-risk cardiovascular patients.
3+ YOEBachelor's degree in science, engineering, or related field; 3+ years in medical device quality systems; knowledge of ISO 13485 and QMSR; strong analytical, organizational, communication, and collaboration skills.
Propel, electronic quality management system (eQMS)
Trystar: Private U.S. manufacturer of electrical power distribution and backup-power equipment for industrial, utility, healthcare, and data-center customers.
3+ YOE3+ years in quality systems/assurance/engineering in manufacturing, working knowledge of ISO 9001, QMS administration (ETQ preferred), audit and CAPA support, Microsoft 365 proficiency, strong communication and attention to detail.
Roquette: Family-owned manufacturer of plant-based ingredients, pharmaceutical excipients, and solutions for food, health, and industry.
3+ YOEBachelor's degree in chemistry, quality assurance, quality management, or quality engineering; 3 years of quality assurance experience in manufacturing; MS Office proficiency and strong technical, leadership, and problem-solving skills.
Microsoft Word, Microsoft PowerPoint, Microsoft Excel
Roquette: Family-owned manufacturer of plant-based ingredients, pharmaceutical excipients, and solutions for food, health, and industry.
3+ YOEBachelor's degree in chemistry, quality assurance, quality management, or quality engineering; 3 years of quality assurance experience in manufacturing; MS Office proficiency and strong technical, leadership, and problem-solving skills.
Microsoft Word, Microsoft PowerPoint, Microsoft Excel, QMS, ISO 9001:2015, FSSC 22000, cGMP, EXCiPACT
TerraPower Isotopes: Private TerraPower subsidiary supplying research-grade actinium-225 to pharmaceutical companies developing targeted cancer therapies.
6+ YOEBachelor's in life sciences/engineering or equivalent; 6+ years in regulated production (3+ years in Quality Systems); experience with GMP/ISO/FDA (21 CFR 210/211), QMS, EDMS/LMS, data integrity (ALCOA+, 21 CFR Part 11); strong technical writing and cross-functional leadership.
Electronic Document Management System (EDMS), Learning Management System (LMS)
TakedaTokyo Stock Exchange: 4502: Global research-driven biopharmaceutical.
Five years of quality experience, preferably in a regulated pharmaceutical or biotechnology environment; knowledge of QMS, cGMP, audits, and quality processes; advanced Excel, analytical, communication, and project management skills.
Microsoft Excel, Quality Management System (QMS), Electronic Quality Management Systems, VLOOKUP, XLOOKUP
Jeppesen: Private aviation software providing flight planning, navigation data, and operations tools to pilots, airlines, and fleets.
6+ years implementing/maintaining quality management systems, 3+ years process improvement experience, strong audit and metrics skills, problem-solving and quality management proficiency.
ISO-9001:2015, ISO 27001:2022, RTCA DO-200B, ED-76A, AC 20-153B, Six Sigma
PCI Pharma Services: Global contract development and manufacturing organization for biopharma.
3+ YOEHigh school diploma required; bachelor's in life sciences preferred. Requires 3–5+ years in quality assurance, quality systems, pharmaceutical manufacturing, biotechnology, or regulated industry, plus GMP and QMS experience.
Merrimack Manufacturing: Private U.S. medical-device contract manufacturer producing lifesaving devices for designers and their patients.
2+ YOEAssociate or bachelor's degree preferred; 2–5 years in quality systems, quality assurance, or a regulated industry. Requires CAPA experience, ISO 13485 and FDA QSR knowledge, root cause analysis, and Microsoft Office proficiency.
Microsoft Office, electronic QMS systems, 5-Why, Fishbone, fault tree analysis
Boeing Distribution Services: Aerospace parts distributor serving aircraft manufacturers, maintenance providers, airlines, and other aviation operators.
5+ YOERequires 5+ years auditing Quality Management Systems and working with ISO9001, AS9100/AS9120, and Microsoft Office. U.S. Person status and domestic travel up to 25% required.
Microsoft Office, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, ISO9001, AS9100, AS9120, AS9110
Ilmor Engineering: British high-performance engine design and manufacturing firm serving racing, marine, automotive, and aerospace customers.
3+ YOESupport and improve QMS per ISO 9001, conduct audits, manage document control, perform root cause analysis, develop KPIs and reports; requires 3+ years quality experience in manufacturing and an associate's degree or equivalent.
ERP, Epicor, Microsoft SharePoint, Microsoft Excel, Microsoft Word, Microsoft PowerPoint, Microsoft Teams
Northridge or California or Seattle or Washington or Boston or New York City or Los Angeles County or United States
$121k-$205k/yrOnsiteFull Time
MedtronicNYSE: MDT: Global leader in medical technology and healthcare solutions.
5+ YOEBaccalaureate degree with 7+ years (or advanced degree with 5+ years) in quality systems; experience with QMS, Change Management, CAPA, audits, and Microsoft Office; strong communication and prioritization skills.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Agile, Trackwise, Microsoft Teams, Microsoft Project, Power BI
Boeing Distribution Services: Aerospace parts distributor serving aircraft manufacturers, maintenance providers, airlines, and other aviation operators.
5+ YOERequires 5+ years conducting quality management system audits and working with ISO 9001, AS9100/AS9120. Requires Microsoft Office proficiency, domestic travel up to 25%, and U.S. person export-control eligibility.
Microsoft Office, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, ISO 9001, AS9100, AS9120, AS9110
5+ YOEBachelor’s degree in life sciences or biopharma with 5+ years of quality systems experience, or 7+ years relevant GLP/GMP experience without a degree; QMS, CAPA, audit, regulatory, analytical, and communication skills required.