19 quality systems specialist jobs at 15 companies in Cold Spring, 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
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%.
VB Spine: A medical technology focused on developing and supporting spinal products and maintaining high quality and regulatory standards.
Bachelor's degree required; knowledge of US and international medical device regulations and QMS elements (CAPA, audits, management review); strong communication, analytical, and project skills; ability to travel 10-15%.
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.
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
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
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.
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.
Bachelor’s degree or equivalent experience, 0–1+ years of B2B experience, excellent English proficiency, and customer support, moderation, or policy experience. Ticketing-system experience preferred.
K&A Engineering Consulting: A privately held engineering firm providing technical and project services to power utility and industrial clients.
2+ YOEBachelor's degree and 2+ years in Six Sigma, quality and environmental management systems, and construction safety; OSHA 30-hour construction course required.
Six Sigma, Quality Management System, ISO 9001, TS-16949, Environmental Management System, ISO 14001, QMS, EMS
K&A Engineering Consulting: An engineering firm delivering consulting, engineering, project management, construction management, and EPC services to power utility and industrial clients.
2+ YOEBachelor's degree, 2+ years in Six Sigma, quality and environmental management systems, and construction safety; ISO standards experience and OSHA 30-hour construction training required.
Six Sigma, ISO9001, TS-16949, ISO 14001, Quality Management System, Environmental Management System, EPC, FSA, HSA, 401K, Roth, Lifestyle Spending Account (LSA), Employee Assistance Program (EAP)
Binghamton or Mechanicville or Brewster or United States
$80k-$90k/yrFieldFull Time
K&A Engineering Consulting: An engineering firm delivering technical and engineering services to power utility and industrial clients.
2+ YOEBachelor's degree; 2+ years in Six Sigma, quality and environmental management systems, and construction safety; OSHA 30-hour construction course; utility construction experience preferred.
Liberty or Binghamton or Mechanicville or Brewster
$80k-$90k/yrFieldFull Time
K&A Engineering Consulting: An engineering firm providing technical and project services to power utility and industrial clients.
2+ YOEBachelor's degree, 2+ years in Six Sigma, quality and environmental management systems, and construction safety; OSHA 30-hour construction course required. Utility project experience preferred.
Manhattan Beer & Beverage Distributors: Wholesale distributor of beer, wine, and spirits in New York.
Accurately pick and build customer orders, use warehouse systems and handheld scanners, lift up to 50 lbs, follow safety and quality standards; previous warehouse/fulfillment experience preferred.
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)
Blythewood or Columbia or San Francisco or Los Angeles or New York City
$110k-$135k/yrOnsiteFull Time
Scout Motors: Designs and manufactures all-electric rugged SUVs and trucks.
8+ YOE8+ years programming robotic paint/sealer applications, degree in engineering or equivalent experience, knowledge of Fanuc/ABB/Duerr systems, FANUC Dispense Tool and Paint Tool/Pro a plus, Lean Six Sigma/process improvement and quality systems experience.
Fanuc, ABB, Duerr, FANUC Dispense Tool, Paint Tool / Pro