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Senior Technical Lead - MDR, ISO 13485, MDD (128769)
United States
OnsiteFull Time
8+ YOEBachelor's in engineering, 8+ years relevant experience, expertise in MDR, ISO 13485, MDD, IEC60601, regulatory compliance for medical devices, strong technical leadership and problem-solving skills.
1w
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SQA Contract Auditor – ISO 9001/ ISO 14001 / ISO 45001 / ISO 13485 / IATF 16949 / AS 91XX / ISO 27001
Fairlawn, Ohio, United States
OnsiteFull Time, Contract
5+ YOEMultiple years of relevant industry experience and lead auditor credentials for specified management system standards (ISO 9001/14001/45001/13485/27001,IATF,AS91XX); demonstrated auditor competency and sector-specific experience.
FMEA, MSA, SPC
2mo
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QMS Internal Auditor
Huntington Beach, California, United States
$126k-$138k/yr OnsiteFull Time
10+ YOE10+ years QA in medical devices; 5+ years internal audits ISO 13485/21 CFR Part 820; ISO 13485 Lead Auditor or ASQ CQA/CQE; Bachelor's degree in Engineering or Life Sciences.
Enlil, ZenQMS, MasterControl, Veeva
1mo
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Post Market Quality Engineer
Warsaw, Indiana, United States
OnsiteFull Time
Conduct post-market complaint investigations, failure and root-cause analyses, risk assessments, and documentation; strong knowledge of 21 CFR 820, ISO 13485, ISO 14971; bachelor’s in engineering or equivalent; ISO 13485 audit and ASQ preferred.
Microsoft Excel, Microsoft Word, Microsoft Outlook, Microsoft PowerPoint, SPC, GD&T
3mo
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Senior Manager, Quality Assurance - Auburn, MA (Auburn, MA, US, 01501)
Auburn, Massachusetts, United States
HybridFull Time
10+ YOE3+ Mgmt10+ years quality experience in medical devices; 7+ years quality auditing; 3+ years leadership; Bachelor's; Lead Auditor cert (ISO 9001 or 13485); knowledge of FDA 21 CFR 820, ISO 13485, MDR; strong communication and analytics.
3mo
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Quality Management System Engineer
Wichita, Kansas, United States
OnsiteFull Time
3+ YOE3+ years in quality management with ISO 9001/13485/AS9100, CAPA, audits, data analysis.
ERP, MES, Statistical Software, Data Analysis Tools
2mo
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Program Manager
Franklin or United States
$106k-$133k/yr OnsiteFull Time
5+ YOEProgram management of medical device projects; budgeting and scheduling; stakeholder coordination; ISO 13485 experience.
Microsoft Project, CAD
1mo
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Sr. Supplier Quality Engineer
Warrendale or Pittsburgh or Cranberry Township
HybridFull Time
5+ YOEMinimum 5 years quality/manufacturing experience, BS in Engineering/Technical Science, ISO 13485 or FDA-regulated device experience, auditing knowledge (ISO 9001/13485), quality tools, manufacturing process knowledge, MS Office and ERP/PLM proficiency, ability to travel up to 30%.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Project, ERP, PLM
2mo
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Engineering Supervisor
Menomonie, Wisconsin, United States
OnsiteFull Time
3+ YOE4-year engineering degree; 3+ years manufacturing engineering; knowledge of ISO9001 or 13485; supervisory experience is desirable.
Microsoft Office
3mo
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Staff Manufacturing Engineer, NPI
Hudson, Wisconsin, United States
$96k-$148k/yr OnsiteFull Time
8+ YOE8+ years of related engineering experience; Lean Six Sigma; ISO 13485 experience; advanced degree preferred.
QSR, ISO 13485, Lean Six Sigma, Process Validation, Kaizen, WIP optimization
1mo
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Manufacturing Quality Engineer
Kentwood, Michigan, United States
OnsiteFull Time
ISO 9001/13485, FDA QSR, GD&T, metrology, statistics, root-cause analysis, continuous improvement.
GD&T, Metrology, Statistical Methods, APQP, PPAP, Gage R&R, DoE, Control Charts, ISO 9001, ISO 13485, FDA QSR
3mo
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Quality Specialist (53723)
United States
$62k-$74k/yr OnsiteFull Time
6+ YOESix years in a regulated industry; two years in quality; ISO 9001/13485, FDA knowledge; document control; audits.
Quality management system, Document control, Audit coordination
2mo
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Metrologist
Brooksville, Florida, United States
OnsiteFull Time
3+ YOE3+ years in dimensional inspection/CMM/metrology; micrometers, calipers, height gauges; calibration systems; ISO 13485 knowledge.
Coordinate Measuring Machine (CMM), Micrometers, Calipers, Height gauges, Indicators, Surface plates, Calibration systems
3mo
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Senior Quality Engineer, Integrated Systems (Exton, PA, US)
Exton, Pennsylvania, United States
HybridFull Time
5+ YOE5+ years in a regulated industry (medical device), quality engineering, ISO 17025/ ISO 13485, cGMP, project leadership.
MasterControl, SAP, SharePoint, Teamcenter, Microsoft Project, Microsoft Excel, Microsoft Word, Microsoft PowerPoint
2mo
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Engineering Supervisor
Menomonie, Wisconsin, United States
OnsiteFull Time
3+ YOEBachelor's degree in engineering; 3+ years progressive Manufacturing Engineering experience; ISO9001/13485 knowledge; supervisory experience preferred.
Microsoft Office, Lean Manufacturing, Lean Six Sigma, ISO standards
3mo
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Quality Engineer (Carson City, Nevada, United States, 89706)
Carson City, Nevada, United States
OnsiteFull Time
3+ YOEQuality Engineer with experience in RMAs/NCRs, supplier audits, process qualification, and quality systems (ISO 9001/13485/AS9100).
Minitab, CMM, Vision Systems, SolidWorks, AutoCAD
2mo
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Production Operator, 1st Shift
Indianapolis, Indiana, United States
OnsiteFull Time
Assemble, test, and package medical devices; operate automated equipment; document processes; follow GMP/ISO-13485 standards.
Manufacturing Equipment, ERP / Documentation Software
3mo
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Validation Inspector - Quality
Denver, Colorado, United States
$20-$23/hr OnsiteFull Time
Inspect parts using drawings, ensure dimensional/quality compliance, ISO 13485, on-site Denver, experience in inspection and manufacturing quality.
Inspection tools, Engineering drawings, QC procedures, 5S
1mo
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Global Supplier Quality Manager
United States
OnsiteFull Time
5+ YOE5+ years in a technical quality role; BS in Engineering; experience with ISO 13485, FDA requirements; supplier audits and CAPA; travel.
Quality Management System (QMS), CAPA, Audit tooling
2mo
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Senior Design Quality Engineer
Phoenix, Arizona, United States
HybridFull Time
4+ YOEBachelor's in engineering; 4+ years in design controls; ISO 13485, CFR 820, ISO 14971; regulator knowledge; experience with eQMS.
eQMS, Quality Management Systems, Regulatory Standards
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