138 quality systems engineer jobs at 117 companies in Berkeley Heights, NJ
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Quality Systems Engineer
Easton, Pennsylvania, United States
OnsiteFull Time
Victaulic: Manufacturer of mechanical pipe joining and flow control systems.
Bachelor's in engineering, experience with quality management systems/enterprise quality software, strong QA documentation/control knowledge, analytical and communication skills, and continuous improvement experience.
quip: Sells electric toothbrushes and subscription-based oral care products.
4+ YOE4+ years in quality engineering/systems; 8+ years in NPD with Asian suppliers; ISO 13485/ISO 9001 auditing; data analysis (Excel, SQL, Python); RCA and teardowns; travel 2-3x/yr; BS/MS in Mechanical or Biomedical Engineering.
AbbVieNYSE: ABBV: Develops and sells innovative pharmaceutical and biopharmaceutical medicines.
5+ YOEBachelor's degree with 5+ years or master's degree with 4+ years relevant experience; cloud application development, LIMS, integrations, SDLC, programming, .NET, AI, analytics, and regulated quality systems expertise required.
4+ YOEBS in science/engineering preferred, 4+ years QMS experience in biopharma/GxP, QA certification preferred, experience with GxP documentation, computerized system validation, audits, training, and quality metrics analysis.
eQMS, eDMS, eLMS, Veeva, ComplianceWire, Ennov, Microsoft Excel, PowerBI
Cartridge Actuated Devices: Manufacturer of high-precision explosive devices and pyrotechnic components.
Bachelor's degree in engineering or a technical field, quality systems knowledge, root cause analysis, FMEA, statistical techniques, process controls, reporting, problem solving, and strong communication skills.
Microsoft Office, NIST 800-171, ISO 9001, AS9100, X-Ray, Leak Tester, oscilloscope, ohmmeter
CompoSecureNYSE: GPGI: Manufacturer of premium metal payment cards and security solutions.
5+ YOERequires 5–10+ years of relevant experience; engineering, science, or mathematics bachelor's degree preferred. Strong quality systems, communication, organization, problem-solving, and Microsoft Office skills required.
Microsoft Office, Microsoft Project, Microsoft Visio, Microsoft Outlook
Prysmian GroupEuronext Milan: PRY: Manufactures power and telecom cables and integrated cabling systems.
0+ YOESupport and improve the Quality Management System, perform statistical analysis, lead root cause investigations, manage corrective/preventive actions, and support audits and customer quality requirements.
LVMHEuronext Paris: MC: A diversified luxury conglomerate managing fashion, spirits, and beauty brands.
5+ YOEBachelor of Science in engineering or technical discipline or equivalent experience; 5+ years related experience, leadership, quality systems, root cause analysis, engineering concepts, coding, data analysis, and strong English communication required.
Python, MATLAB, VBA, Microsoft Excel, Microsoft PowerPoint, Microsoft Word, Microsoft Visio, Microsoft Power Apps, Microsoft Access, Power BI
Quality Systems Manager – Medical Device Manufacturing
Fairfield, New Jersey, United States
OnsiteFull Time
Weiss-Aug Group: Provides precision metal stamping and injection molding manufacturing solutions.
10+ YOE10+ years in medical device quality systems; ISO 13485 and FDA QSR experience; manage QMS, audits, and regulatory readiness; Bachelor’s in Engineering or Quality.
Electronic QMS platforms, ISO 13485, FDA QSR, 21 CFR Part 820
AmazonNASDAQ: AMZN: Global online retail and cloud computing technology provider.
5+ YOERequires 5+ years of quality engineering in hardware products, contract manufacturing quality systems, inspection and metrology, functional testing, and production documentation. Master's degree and robotics experience preferred.
QMS, First Article Inspection (FAI), Non-Conformance Reports (NCRs), CAPAs, Design for Manufacturability (DFM), Design for Testability (DFT), DFMEA, PFMEA, UL, CE, RoHS, UN38.3, Environmental Stress Screening (ESS), Accelerated Life Testing (ALT), Arena, ETQ, Greenlight Guru, IPC-A-610, IPC-J-STD-001
EXALTA: Designs and manufactures orthopedic medical devices and surgical instruments.
5+ YOE5+ years quality engineering/metrology experience, MSA/Gauge R&R expertise, CMM and vision system experience, GD&T knowledge, statistical analysis, and ability to develop/qualify inspection methods.
GetingeNasdaq Stockholm: GETI B: Manufactures medical equipment for acute care and life sciences.
5+ YOEBachelor's degree in engineering or science, 5+ years in quality assurance or engineering, regulated-industry experience, quality systems, statistical analysis, project leadership, and Microsoft Office proficiency.
IDEXNYSE: IEX: Designs and manufactures specialized fluidic, optical, and industrial systems.
5+ YOEBachelor's in engineering, 5+ years quality/manufacturing experience, ISO 9001 knowledge, root cause analysis, GD&T, SPC, measurement systems, Microsoft Office proficiency, strong communication and problem-solving skills.
Marotta Controls: Designs and manufactures precision control systems for aerospace and defense.
3+ YOEBachelor's in engineering, 3+ years quality/manufacturing engineering experience, supplier quality/aerospace experience preferred, knowledge of quality systems, audits, SPC, root cause analysis, and ability to obtain security clearance.
MS Excel, MS Word, MS PowerPoint, Coordinate Measuring Machine (CMM), Vision System, IPC J STD-001E, NASA STD-8739, IPC 610, AS9100, ISO, SPC, PFMEA, Six Sigma
PearsonLondon Stock Exchange: PSON: Provide educational materials, assessments, and digital learning services globally.
8+ YOE8+ years in quality engineering; hands-on testing of AI/LLM systems; automation with Playwright or similar; proficiency in JavaScript/TypeScript or Java; API testing, CI/CD integration; experience leading QE teams.
CooperSurgicalNasdaq: COO: Manufactures medical devices for fertility and women's health.
7+ YOERequires 7+ years in regulated quality environments, 5+ years in supplier quality management, and a bachelor's degree or equivalent experience. Expertise in supplier audits, risk management, SCAR/CAPA, regulatory standards, and quality systems.
FDA QSR (21 CFR 820), ISO 13485, EU MDR, ISO 14971, Minitab, Microsoft Office, ERP, eQMS, SCAR, CAPA, FMEA, NCMRs, SCNs, NPI, IQ, OQ, PQ, PPAP, QMS
PearsonLondon Stock Exchange: PSON: Global education providing learning materials and assessments.
8+ YOE8+ years in quality engineering, hands-on testing of AI/LLM systems, automation with Playwright or comparable frameworks, proficiency in JavaScript/TypeScript and/or Java, API/data validation, and QE leadership experience.
Englewood LabKOSDAQ: 950140: Contract manufacturer of skincare and OTC cosmetic products.
2+ YOEBachelor’s degree in science, quality, engineering, or related field; 2–4 years in quality functions within regulated manufacturing; audit, CAPA, validation, supplier quality, data integrity, and statistical tool experience.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, ERP, FMEA, Six Sigma, Kaizen, PDCA, DMAIC, Fishbone, Ishikawa, ALCOA+, cGMP, ISO 22716, ISO 19011, 21 CFR 210/211
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.