33 quality systems specialist jobs at 25 companies in Whitestone, NY
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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
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
VB Spine: Family-owned medical technology that manufactures spine implants, surgical instruments, and navigation solutions for surgeons and patients.
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: Family-owned aerospace and defense manufacturer making control systems for military and commercial spacecraft, aircraft, ships, and submarines.
5+ YOE0-5 years in quality functions; AAS preferred; US citizen; security clearance eligible; AS9100 knowledge; strong communication; MS Office proficiency.
BDNYSE: BDX: Global medical technology advancing the world of health.
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.
Le Papillon: Private manufacturer of tubular glass vials, containers, closures, and decorating services for beauty, diagnostic, and laboratory customers.
Experience preparing fill/assembly specifications, BOM and MRP analysis, familiarity with FDA/ISO/global quality standards, SAP and Monarch (MRP) systems, and investigating nonconformances.
Janssen Biotech, Inc.: Janssen Biotech is a Johnson & Johnson biopharmaceutical developing biologic and small-molecule therapies for patients.
Bachelor's degree in science, information science, or equivalent technical discipline; 2+ years in quality assurance, quality systems, or compliance; knowledge of cGMP/GTP, FDA, and international regulations.
Good Documentation Practices (GDP), Standard Operating Procedures (SOPs), cGMP, GTP, FDA, CAR-T
Janssen Biotech, Inc.: Janssen Biotech is a Johnson & Johnson biopharmaceutical developing biologic and small-molecule therapies for patients.
2+ YOEBachelor's degree in science, information science, or equivalent technical discipline; 2+ years in quality assurance, quality systems, or compliance; knowledge of cGMP, GTP, FDA, and international regulations.
Kuehne+NagelSIX Swiss Exchange: KNIN: Global provider of integrated logistics and supply chain 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: Global provider of integrated 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
Kuehne+NagelSIX Swiss Exchange: KNIN: Global provider of integrated logistics and supply chain services.
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
ConnectiveRx: Private biopharmaceutical services providing hub, affordability, and adherence support to pharmaceutical manufacturers, providers, and patients.
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
Aerojet Rocketdyne: Aerospace and defense manufacturer of rocket propulsion, power, armament and missile systems for government and prime contractors.
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: Public clinical biopharmaceutical developing psychedelic treatments for anxiety, depression, PTSD, and autism spectrum disorder.
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
WuXi BiologicsHong Kong Stock Exchange: 2269: Public biologics CRDMO serving biopharmaceutical companies with research, development, and manufacturing services worldwide.
1+ YOEHigh school certificate or degree in chemistry, microbiology, biochemistry, or equivalent; relevant QC experience preferred. English proficiency and familiarity with pharmaceutical cGMP regulations, analytical instruments, and laboratory systems required.
HarrowThe Nasdaq Stock Market LLC: HROW: Public North American ophthalmic pharmaceutical developing, commercializing, and compounding eyecare medicines for U.S. professionals and patients.
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
Maquet: German medical technology manufacturer supplying surgical, cardiovascular, critical-care, and operating-room equipment to hospitals.
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: Global consumer healthcare providing self-care solutions.
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, Inc.: Private payments and POS serving restaurant and retail merchants with hardware, software, ordering, and management 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.
American Regent, Inc.: Daiichi Sankyo-owned U.S. pharmaceutical manufacturer of sterile generic and branded injectables for healthcare providers and animal-health customers.
2+ YOEBachelor's degree in science or engineering or equivalent experience, 2–5 years in pharmaceutical aseptic manufacturing, gown qualification, GMP and quality systems knowledge, and strong communication and organizational skills.
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.