20 quality systems specialist jobs at 16 companies in Minnesota
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Quality Systems Specialist
Eden Prairie, Minnesota, United States
$70k-$800k/yrOnsiteFull Time
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.
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.
IMRIS: Private medical device manufacturer designing, installing, and servicing intraoperative MRI operating suites for hospitals and cancer centers.
5+ YOEBachelor's degree preferred; 5–8 years in quality assurance, quality systems, regulatory affairs, or a regulated industry, with CAPA, recall, audit, QMS, and medical device experience preferred.
Microsoft Office, Quality Management System (QMS), MDSAP
Imricor Medical SystemsASX: IMR: U.S. medical device manufacturer developing MRI-compatible products for physicians performing image-guided cardiac ablation.
3+ YOEBachelor’s degree in a related technical field; 3-5 years QA or quality systems in medical device; CAPA and nonconformance; knowledge of 21 CFR Part 820, ISO 13485, EU MDR; strong data analysis and communication.
RISE Modular: Minneapolis-based volumetric modular manufacturer and construction serving multifamily and hospitality developers.
2+ YOEAssociate or bachelor's degree in quality control or related field, or equivalent experience, plus 2+ years in quality assurance within manufacturing or construction. Requires auditing, inspection, quality systems, communication, and presentation skills.
STERISNYSE: STE: Global provider of infection prevention and sterilization solutions.
2+ YOEAssociate degree and 2 years of quality experience in a regulated industry, or high school diploma/GED and 6 years of experience. Manufacturing, quality systems, document control, and MS Office experience preferred.
Microsoft Office, Microsoft Excel, Microsoft PowerPoint, Propel, Windchill, SAP, ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR, CAPA, NCR
Velosity: Private Minnesota contract manufacturer providing molding, machining, tooling, and assembly for medical-device and defense OEMs.
2+ YOE3–5 years of quality experience preferred, including at least 2 years in plastic injection molding or equivalent; requires quality systems knowledge, Microsoft Office and IQMS experience, communication, problem-solving, and independent work.
Boston ScientificNYSE: BSX: Global medical technology leader providing innovative solutions for patients.
5+ YOEBachelor's degree, 5+ years clinical QA experience including GCP audits, working knowledge of ISO 14155/13485/GCP/GMP/GDP, CAPA and quality systems experience, ability to travel up to 30%.
ISO 14155, ISO 13485, Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), Good Documentation Practice (GDP)
Dairy Farmers of America: A national farmer-owned cooperative marketing milk and dairy products.
1+ YOEHigh school diploma, 1–3 years food manufacturing quality or food safety experience; familiarity with quality systems, record keeping, audits, and strong written/verbal English communication.
H2O Innovation: Canadian private water-solutions providing treatment equipment, specialty products, and operations services to municipal and industrial customers.
Experience in document control and quality systems, strong Microsoft Office skills, knowledge of ISO 9001, willingness to travel up to 20%, and attention to detail for managing controlled documents and migrations.
Microsoft Word, Microsoft Excel, Microsoft SharePoint, Microsoft Outlook, Power Automate, Power Apps, Microsoft 365
Micro-Matics: Private U.S. manufacturer of custom Swiss-machined components for medical, aerospace, defense, semiconductor, and commercial customers.
5+ YOEBachelor’s degree or equivalent experience, plus two-year post-education or five years of relevant experience. Requires ISO 13485 and AS9100 compliance knowledge, auditing, CAPA, document control, and quality-system administration.
Teleflex IncorporatedNYSE: TFX: Global provider of medical technology solutions for healthcare.
5+ YOEBachelor's degree preferred and 5+ years in engineering document control, PLM, or change management within regulated medical devices. Requires PLM, ERP, and quality systems experience plus strong analytical and communication skills.
Product Lifecycle Management (PLM), Quality Management System (QMS), Enterprise Resource Planning (ERP), Oracle Agile, SAP S/4HANA/MDG, Windchill, Arena
Schneider ElectricEuronext Paris: SU: Global energy technology leader in management and automation.
3+ YOEDeploy and commission electrical power monitoring systems; must have electrical and power quality knowledge, Modbus/Profibus/Bacnet experience, ability to travel, and valid US motor vehicle operation.
Boston ScientificNYSE: BSX: Global medical technology leader providing innovative solutions for patients.
2+ YOECollege degree or equivalent experience, minimum 2 years supporting sales/service operations, experience with quality and business systems; SAP and SalesForce experience preferred.
Boston ScientificNYSE: BSX: Global medical technology leader providing innovative solutions for patients.
2+ YOECollege degree or equivalent experience, minimum 2 years supporting sales or service operations, experience with quality/business systems; SAP and SalesForce experience preferred.
Belgium or Singapore or Saint Thomas or Pago Pago or Brussels or Brasília or Halifax or Montreal or Ansbach or Guam or Saipan or Panama City or Warsaw or San Juan or Abu Dhabi or Texas or Virginia or Washington or Wisconsin or Alabama or California or Colorado or Florida or Georgia or Idaho or Illinois or Indiana or Kansas or Kentucky or Maryland or Massachusetts or Michigan or Minnesota or Mississippi or Missouri or Montana or Nebraska or Nevada or New Hampshire or New Jersey or New Mexico or New York or North Carolina or North Dakota or Ohio or Oklahoma or Oregon or Pennsylvania or Rhode Island or South Carolina or South Dakota or Tennessee or Utah or Vermont or West Virginia or Wyoming or Alaska or Arizona or Arkansas or Connecticut or Delaware or District of Columbia or Hawaii or Iowa or Louisiana or Maine or New Hampshire or New Mexico or Oklahoma
$131k-$228k/yrOnsiteFull Time
Federal Aviation Administration: U.S. agency regulating civil aviation and national airspace.
1+ YOERequires one year of specialized experience equivalent to FV-J or FG/GS-14, including aviation safety programs, regulatory compliance, quality management systems, and operational risk analysis.
Laborie Medical Technologies: Privately owned medical-device manufacturer serving clinicians and hospitals with diagnostic/therapeutic products in urology, gastroenterology, and obstetrics.
1+ YOEBachelor's degree in science/engineering,1-3 years regulatory affairs experience in medical device industry,experience with international registrations and quality system regulations,strong communication and organization skills.
Principal Regulatory Affairs Specialist – Vascular (on-site)
Saint Paul, Minnesota, United States
$87k-$173k/yrOnsiteFull Time
AbbottNYSE: ABT: Global healthcare technology focused on life-changing medical innovations.
5+ YOEBachelor’s degree in a scientific discipline and regulatory submissions experience for medical devices, with knowledge of FDA, international regulations, quality systems, and clinical investigations; 5+ years preferred.
GTS, Quality Management Systems (QMS), Environmental Management Systems (EMS), word processing software, spreadsheet software, presentation graphic software
Veeva Vault System Senior Specialist (Night Shift: 6 PM - 2 AM EST)
Woodbury or United States
$82k-$108k/yrRemoteFull Time
Kindeva Drug Delivery: Private global drug-delivery CDMO developing and manufacturing injectable, inhaled, nasal, transdermal, and intradermal products for pharmaceutical companies.
2+ YOEMinimum 2 years in quality systems, document control, IT support, regulated operations, validation, or life sciences systems; 5 years with a bachelor's or 3 with a master's in pharma or biotech; Veeva administration certification.
Veeva Vault, Microsoft Office, Microsoft Excel, Microsoft Word, Microsoft PowerPoint, Microsoft Teams, Microsoft Outlook