63 quality systems engineer jobs at 46 companies in Roebling, NJ
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Quality Systems Engineer
Easton, Pennsylvania, United States
OnsiteFull Time
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.
3mo
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Quality Management Systems Engineer
Warren, New Jersey, United States
$100k-$120k/yr HybridFull Time
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
3w
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Quality Engineer
Somerset, New Jersey, United States
$70k-$162k/yr OnsiteFull Time
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
1mo
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Quality Engineer
Bridgewater, New Jersey, United States
OnsiteFull Time
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.
Microsoft Excel, Microsoft Office
3mo
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Quality Systems Manager – Medical Device Manufacturing
Fairfield, New Jersey, United States
OnsiteFull Time
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
3w
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Sr. Quality Engineer
Marquette or Bethlehem
OnsiteFull Time
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.
CMM, vision systems, Gauge R&R, MSA
2w
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Supplier Quality Engineer - Mechanical
Hatfield, Pennsylvania, United States
OnsiteFull Time
5+ YOEBachelor's degree in Mechanical Engineering, 5+ years of industry experience, including 2+ years in supplier quality or supply chain management; quality systems, statistical methods, communication, and problem-solving skills required.
DOE, SPC, TQM, ISO-9001, AS9100, ANSI Y14.5, GD&T, RoHS, REACH, FMEA, gauge R&R, ECN, Microsoft Excel
3mo
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Quality Assurance Engineer II
Plainsboro, New Jersey, United States
$71k-$98k/yr OnsiteFull Time
3+ YOEBachelor’s in Science or Engineering; 3-5+ years QA in medical device/pharmaceutical manufacturing; knowledge of investigations, root cause analysis, CAPA, and quality systems; strong organizational and communication skills; proficient with MS Office; able to work independently.
Microsoft Office, Statistical software
2mo
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Qual Systems Manager
Somerset, New Jersey, United States
OnsiteFull Time
8+ YOELead and maintain QMS compliant with ISO/FDA/GMP, manage audits and CAPA, supervise quality staff, bachelor's in engineering/quality, 8+ years manufacturing quality experience, ASQ/Lead Auditor/Six Sigma preferred, advanced Excel skills.
Microsoft Office, Microsoft Excel
2mo
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Quality Manager
Princeton or Plainsboro
OnsiteFull Time
3+ YOEBachelor's degree in supply chain/engineering or related field, 3+ years in customer-facing quality roles, expertise in SAP Quality Management, ERP/CRM systems, ISO 9001/14001, advanced problem-solving (8D, 5-Why, Lean, Six Sigma, SPC), and experience with NPDI and reliability engineering.
SAP Quality Management, ERP, CRM
2d
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Customer Quality Product Investigation Engineer Site Liaison
Palm Beach Gardens or Warsaw or West Chester
HybridFull Time
1+ YOEBachelor's or equivalent engineering degree, 1–2 years of experience, failure analysis and investigation experience, orthopedic product and complaint system knowledge, and strong analytical, communication, and collaboration skills.
Customer Complaint Systems, Key Process Indicators (KPI), Six Sigma, GAMP, Lean Supply Chain Management
1mo
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Quality Engineering Manager
Eatontown, New Jersey, United States
$134k-$165k/yr OnsiteFull Time
6+ YOEU.S. person required. 6+ years quality engineering experience, Bachelor's degree, strong knowledge of quality management systems, experience leading teams, AS9100 and regulatory knowledge preferred.
1mo
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Senior Manager, Quality Engineering
Branchburg, New Jersey, United States
$125k-$237k/yr OnsiteFull Time
8+ YOE4+ MgmtBachelor's in science or engineering, 8+ years pharma/biologics/device experience, 4+ years supervisory experience, knowledge of cGMP and quality systems, statistical methods, and quality engineering practices.
2mo
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Quality System Engineer
Oak Brook Terrace or Myrtle Beach or Avon or Atlantic Beach or Destin or Simons Island or Charleston or Sabine Pass or West Palm Beach or Sanibel or St. Simons Island or Norfolk or Venice or Atlantic Beach or Galveston or Sulphur or Mobile or Fort Lauderdale or Port Isabel or Freeport or San Antonio or Austin or Dallas or Little Rock or Staten Island or Cape Girardeau or Morgan City
OnsiteFull Time
3+ YOEBachelors in engineering required; 3+ years marine construction/excavation/earthworks experience; USACE/NAVFAC experience preferred; strong communication and computer skills.
Microsoft Office, Microsoft Excel, Microsoft Word, AutoCAD, USACE Resident Management System (RMS), RMS 3.0, Primavera P6, Adobe
2w
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Supplier Quality Manager
Charlotte or Philadelphia or Stockholm
OnsiteFull Time
5+ YOERequires 5+ years in quality assurance or management, supplier auditing experience, a bachelor's in engineering or life science, English fluency, and knowledge of regulated quality systems and continuous improvement.
Microsoft Office, DocuSign, electronic QMS systems, ISO 13485, ISO 14971, US-FDA QSRs, EU-MDR, Six Sigma, AI applications, predictive analytics
4w
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Quality Assurance Specialist
Bethlehem, Pennsylvania, United States
OnsiteFull Time
5+ YOE5+ years QA experience, Associate or Bachelor in science/engineering, knowledge of ISO 9001 and quality systems, strong communication and spreadsheet/database skills, able to travel up to 50%.
1d
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Director, Quality Inspection Management
Hampton, New Jersey, United States
$177k-$229k/yr OnsiteFull Time
10+ YOEBachelor's degree in a relevant life sciences or engineering field and 10+ years in quality assurance, GMP compliance, regulatory inspection management, or quality systems in biotechnology, pharmaceuticals, or biologics manufacturing.
GMP, FDA, EMA, MHRA, ICH, CAPA, CDMO
6d
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Sr. Manager Quality IT
Bridgewater, New Jersey, United States
$127k-$167k/yr OnsiteFull Time
10+ YOE5+ MgmtBachelor’s degree in science, IT, engineering, or equivalent; 10+ years in pharmaceutical, biotech, or medical device industries, including 5+ years of leadership; experience with GxP, quality systems, validation, and regulatory compliance.
Quality Management System (QMS) software, document control, validation tools, change control systems, Laboratory Information Management System (LIMS), Veeva, Enterprise Resource Planning (ERP) systems, SAP, Computerized System Validation (CSV), Software Development Life Cycle (SDLC), FDA 21 CFR Part 11, FDA 21 CFR Part 210, FDA 21 CFR Part 211, EU Annex 11, GAMP5
2w
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Level I Quality Assurance Specialist
Philadelphia, Pennsylvania, United States
$80k-$90k/yr OnsiteFull Time
5+ YOEHigh school diploma or GED plus military, trade, industrial, or engineering school training; five years of quality systems experience meeting MIL-I-45208 or ISO 9000 standards.
MIL-I-45208, ISO 9000
2d
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Associate Director, Quality Assurance
West Point or United States
$129k-$203k/yr HybridFull Time
8+ YOEBachelor's degree in science, IT, or engineering; 8+ years of regulated pharmaceutical or related audit experience; GLP expertise, audit leadership, regulatory compliance, quality systems, and cross-functional leadership required.
Microsoft PowerPoint, Microsoft Excel, Microsoft Word, Pristima, Veeva, Laboratory Information Management Systems (LIMS), Empower
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