33 quality systems specialist jobs at 23 companies in Everett, MA
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Principal Quality Systems Specialist
Northridge or California or Seattle or Washington or Boston or New York City or Los Angeles County or United States
$121k-$205k/yrOnsiteFull Time
MiniMed GroupNasdaq: MMED: A medical device developing insulin delivery systems and connected care solutions for people living with diabetes.
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
ABCorp: Produces secure payment cards and provides additive manufacturing solutions.
5+ YOE5+ years in quality assurance/systems in regulated manufacturing; experience with CAPA, deviations, investigations, change and document control, audits, SOPs, root cause analysis, QMS/ERP, and strong written documentation and cross-functional collaboration.
Kymera TherapeuticsNASDAQ: KYMR: Develops targeted protein degradation medicines to treat human diseases.
5+ YOEBachelor's in life sciences, 5+ years quality systems/GxP/document control experience in a sponsor organization, hands-on eQMS administration, GxP training program management, knowledge of 21 CFR Part 11 and ICH E6(R3).
Veeva Vault, Microsoft Word, Microsoft Excel, Microsoft PowerPoint
WHOOP: Wearable technology for personalized health and performance tracking.
2+ YOEBachelor's in engineering or life sciences,2+ years QMS/QA experience in medical device or digital health,working knowledge of ISO 13485 and 21 CFR Part 820,QMS processes (CAPA,complaints,audits),and eQMS experience.
HexcelNYSE: HXL: Produces advanced composite materials for aerospace and industrial applications.
HS/GED required; proficiency with Microsoft Office; experience supporting CMMS, LMS, DMS, NCM/CAPA and calibration databases; records management, report generation, strong written and verbal communication; U.S. citizenship required.
CMMS, LMS, DMS, NCM, CAPA, Microsoft Word, Microsoft Outlook, Microsoft Excel, Microsoft PowerPoint
EmersonNYSE: EMR: Engineering industrial automation and software solutions for global industries.
High school diploma/GED, exceptional attention to detail, process-oriented, proficiency in Microsoft Word and Excel, familiarity with ASME and Oracle systems preferred, legal US work authorization required.
Boston ScientificNYSE: BSX: Developer and manufacturer of innovative medical devices and therapies.
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)
4+ YOE4+ years cGMP experience, ability to interpret SOPs/regulations, strong written/verbal skills, data interpretation, experience with quality management systems and GxP electronic systems; Bachelor's in STEM preferred.
BMSDocs, CELabs, MES, SAP, ValG, DeltaV, Maximo, Infinity, Microsoft Power Automate, Smartsheet, Tableau, Microsoft Office
Dana-Farber Cancer Institute: Provides comprehensive cancer treatment and conducts oncological research.
Experience in cell processing quality systems, auditing, regulatory compliance (FACT, FDA, JCAHO, AABB, CLIA), proficiency with databases and spreadsheets, strong analytical and communication skills.
Bristol Myers SquibbNew York Stock Exchange: BMY: Develops and distributes innovative medicines for serious diseases.
4+ YOE4+ years cGMP experience (1+ year site manufacturing preferred). Bachelor's in STEM preferred (HS/Associates with experience considered). Proficiency with quality systems, data interpretation, MS Office and digital tools; strong communication and decision-making skills.
BMSDocs, CELabs, MES, SAP, ValG, DeltaV, Maximo, Infinity, Microsoft Power Automate, Smartsheet, Tableau, MS Office
Iterative Health: Develops AI-driven precision medicine for gastrointestinal clinical research.
Experience with clinical research operations and CTMS; ability to configure study systems, perform quality control/UAT, interpret protocols, and collaborate cross-functionally.
CRIO, RealTime CTMS, Clinical Trial Management Systems (CTMS), Microsoft Excel, Microsoft Word, Microsoft PowerPoint, Microsoft Outlook, Microsoft Teams, Adobe
LonzaSIX Swiss Exchange: LONN: Manufactures medicines and provides development services for healthcare companies.
3+ YOEBachelor's in computer science or engineering; 3+ years CSV experience; 3+ years in a cGMP facility; experience with 21 CFR Part 11 and ISPE GAMP; background in biotech/pharma/medical devices; ability to work on-site in Portsmouth, NH.
Boston ScientificNYSE: BSX: Developing and manufacturing innovative medical devices for less-invasive treatments.
5+ YOEBachelor's degree in science/engineering/health-related field, 5+ years clinical QA or clinical research compliance experience, 5+ years conducting GCP/regulatory audits, knowledge of ISO 14155/13485/GCP/GMP/GDP, CAPA and quality systems experience.
Commonwealth of Massachusetts: Providing public services and governance to the people of Massachusetts.
3+ YOEMinimum 3 years EDP experience including 1 year systems analysis; ability to collect user requirements, write specs and test plans; familiarity with SaaS, workforce development programs, federal/state reporting, and testing/documentation.
SaaS, CRM, analytics platforms, Microsoft Office, SharePoint, Teams
PCI Pharma Services: Integrated pharmaceutical development, manufacturing, and global packaging services.
2+ YOERequires 2+ years in GMP, ISO, or FDA-regulated environments, quality-system technical writing, cGMP investigations, root-cause and risk analysis; science or engineering bachelor's preferred.
Sun PharmaNSE: SUNPHARMA: Develops and manufactures generic and specialty pharmaceutical products worldwide.
3+ YOEKnowledge of GMP and quality systems, 3+ years supporting manufacturing or quality, CAPA/change control/deviation experience, training compliance tracking, documentation and QMS familiarity.
Care New England Health System: Integrated non-profit health system providing hospital and medical services.
3+ YOERhode Island RN licensure, 3–5 years of community behavioral health nursing experience, nursing degree, driver's license, insured vehicle, analytical skills, and proficiency with electronic health records and data reporting systems.
electronic health records, data reporting systems, Plan-Do-Study-Act (PDSA), Root Cause Analysis (RCA), Continuous Quality Improvement (CQI)
Borg Design: Borg Design provides precision CNC machining and contract manufacturing services.
2+ YOE2+ years purchasing or supply chain experience in precision manufacturing; knowledge of metals, tooling, supplier certifications, material traceability, and relevant quality/compliance standards; proficient with Microsoft Office and ERP systems.
United States or Boston or New York City or Providence or East Coast
$100k-$130k/yrHybridFull Time
Volta Medical: AI-driven decision support for cardiac arrhythmia treatments.
3+ YOEBachelor's degree or equivalent experience; 3+ years supporting cardiac medical devices in hospitals; troubleshooting electromechanical and software systems; customer-facing field service experience; medical device quality knowledge.
ERP, RMA, Quality Management Systems (QMS), ISO 13485, FDA Quality System Regulation (QSR/QMSR)