33 quality systems specialist jobs at 25 companies in Hell's Kitchen, NY
2mo
Save
Mark Applied
Hide
2mo
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
VB Spine: A mission-focused medical technology dedicated to innovation and improving patient outcomes in spine care.
Bachelor's degree required; knowledge of US and international medical device regulations, QMS elements (CAPA, audits, management review), strong communication, analytical and project skills, computer literate; ability to travel 10-15%.
Marotta Controls: Designs and manufactures precision control systems for aerospace and defense.
5+ YOE0-5 years in quality functions; AAS preferred; US citizen; security clearance eligible; AS9100 knowledge; strong communication; MS Office proficiency.
Maxxima: Designs and manufactures LED lighting for various industrial markets
7+ YOEBachelor’s degree or equivalent experience; 7+ years in quality systems or assurance; ISO 9001 QMS ownership; audit leadership; CAPA, root cause analysis, document control, and continuous improvement expertise.
ISO 9001, Quality Management System (QMS), TISAX, C-TPAT, QT9 QMS, ISO 27001, UL, ETL, DOT
BDNYSE: BDX: Manufactures medical devices, surgical instruments, and pharmacy automation systems.
8+ YOEBS in engineering or science,8+ years medical device/biologic/pharmaceutical/diagnostic experience,knowledge of 21CFR820,ISO13485,MDR/MDD,MDSAP,audit and CAPA expertise.
Arcade Beauty: Manufacturer of product samples and packaging for beauty brands.
Experience preparing fill/assembly specifications, BOM and MRP analysis, familiarity with FDA/ISO/global quality standards, SAP and Monarch (MRP) systems, and investigating nonconformances.
Kuehne+NagelSIX Swiss Exchange: KNIN: Provides global freight forwarding and supply chain management services
1+ YOEHigh school diploma or equivalent, Microsoft Office Suite and order entry system proficiency, and 1–2 years of warehouse, quality inspection, or auditing experience.
Kuehne+NagelSIX Swiss Exchange: KNIN: Provides global logistics, freight forwarding, and supply chain solutions.
1+ YOEHigh school diploma or equivalent, Microsoft Office Suite and order entry systems proficiency, and 1–2 years of warehouse, quality inspection, or auditing experience in logistics or contract environments.
Microsoft Office Suite, order entry systems, ISO, GxP, IATA CEIV
Kuehne+NagelSIX Swiss Exchange: KNIN: Global provider of logistics and supply chain services.
1+ YOEHigh school diploma or equivalent, proficiency in Microsoft Office Suite and order entry systems, and 1–2 years of warehouse, quality inspection, or auditing experience in logistics or contract environments.
Microsoft Office Suite, order entry systems, ISO, GxP, IATA CEIV
ConnectiveRx: Technology-enabled patient support and medication access solutions.
5+ YOEBachelor's degree or equivalent in science, quality, healthcare, or related field; 5–7 years of quality systems experience, including 3+ years leading audits and enterprise-scale cross-functional teams.
Electronic Learning Management System, Information Security
Digital Quality Systems Specialist- Data Analytics, Governance and Automation
Piscataway, New Jersey, United States
$97k-$137k/yrHybridFull Time
Colgate-PalmoliveNYSE: CL: Manufactures and sells oral, personal, home, and pet care.
4+ YOEBachelor's degree, 4+ years as digital systems SME, experience with QMS/LIMS/ETQ/TrackWise, BI tools (Sigma/Streamlit), SQL, GxP and data integrity (21 CFR Part 11/Annex 11).
L3Harris TechnologiesNYSE: LHX: Aerospace and defense providing mission-critical technology solutions.
6+ YOEBachelor's degree plus 6 years' relevant experience, graduate degree plus 4 years, or 10 years without a degree. Requires AS9102/PPAP, auditing, quality systems, inspection, and manufacturing experience.
Definium TherapeuticsNasdaq: DFTX: Develops psychedelic-based pharmaceutical treatments for psychiatric disorders.
7+ YOE7+ years pharma/biotech experience, 5+ years CSV lifecycle experience, bachelor\u0002s in life science, strong knowledge of 21 CFR Part 11/GAMP 5/GDPR, SaaS validation, and AI/ML system assessment.
GAMP 5, 21 CFR Part 11, GDPR, SDLC, Computer System Validation (CSV), Computer System Assurance (CSA), AI/ML, SaaS, PaaS
Chamblee or Holtsville or Cincinnati or Philadelphia or Pittsburgh or Austin or Dallas
$63k-$114k/yrOnsiteFull Time
IRS Office of Chief Counsel: Represents the IRS in tax litigation and legal matters.
1+ YOESpecialized experience in taxpayer account management, quality review, contact recording, IRS systems, Microsoft Outlook, Excel and Word, ITLA, publications and IRMs; bilingual English and Spanish proficiency required.
Verint, Ultra, Contact Recording, Embedded Quality Review System, National Quality Review System, Individual Master File (IMF), Outlook, Microsoft Excel, Microsoft Word, IDRS, AMS, IAT, RTR, Interactive Tax Law Assistant (ITLA), IRS Publications, IRMs, ALTA Language Assessment, USA STAFFING, USAJOBS
HarrowNasdaq: HROW: Develops and commercializes pharmaceutical products for managing ophthalmic diseases.
3+ YOERequires 3+ years of cGMP and aseptic drug manufacturing experience, high school diploma, quality systems knowledge, strong computer and communication skills, critical thinking, and schedule flexibility.
Microsoft Word, Microsoft PowerPoint, Microsoft Excel
GetingeNasdaq Stockholm: GETI B: Manufactures medical equipment for acute care and life sciences.
5+ YOEBachelor's or Master's in statistics/data science/mathematics,5+ years relevant experience,expertise in statistical analysis,AI/ML fundamentals,NLP,predictive analytics,and communicating complex findings.
Power BI, Tableau, SQL, Python, R, Microsoft Fabric, Databricks, Snowflake, Azure analytics tools, Microsoft Copilot
Opella: Develops and manufactures consumer healthcare and self-care products.
3+ YOEBachelor’s degree in a technical discipline or equivalent experience; 3+ years of quality compliance experience in a regulated industry; FDA, cGMP/GDP, investigation, root cause analysis, and quality systems experience.
Bluu: Provides point-of-sale hardware and merchant payment processing solutions.
Bilingual Korean and English QA specialist with software testing, POS or payment systems, Windows or Android testing, test case and technical documentation experience, basic SQL and API testing knowledge.
Merck & Co.NYSE: MRK: Develops and manufactures prescription medicines, vaccines, and animal health products.
4+ YOEBachelor's degree in engineering, life sciences, chemistry, or related field; 4+ years of pharmaceutical or GMP manufacturing experience; experience with investigations, CAPAs, audits, and quality systems.
United Arab Emirates or Philippines or New York or India or Japan or Brazil or Austria or Poland
RemoteFull Time
Entrupy: AI-powered platform for instant authentication of high-value physical goods.
Native Japanese and business English, strong analytical skills, attention to detail, comfort with large datasets, tech-savvy with internal systems and collaboration tools, flexible to work weekends/holiday hours.