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
2w
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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.
5d
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Associate Principal Scientist/Engineer, Medical Device and Combination Products, ISO/DV Testing Manager
West Point, Pennsylvania, United States
$142k-$224k/yr OnsiteFull Time
3+ YOEBS/MS/PhD in engineering or science, 3+ years (PhD) or 6+ years (BS/MS) in analytical testing in cGMP/ISO 13485 labs, mechanical testing experience, leadership and compliance skills.
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 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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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
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
2mo
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Senior Engineer I, Quality (Delivery System)
Irvine, California, United States
OnsiteFull Time
4+ YOEBachelor's in engineering; 4+ years medical device quality/regulatory experience; familiarity with 21 CFR 820, ISO 13485, ISO 14971.
2w
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Quality Assurance Associate at Biotech Company-Bothell, WA
Bothell, Washington, United States
OnsiteFull Time
2+ YOEBachelor's degree or equivalent, minimum 2 years in FDA/ISO regulated environment, knowledge of ISO 13485/9001 and FDA QSR preferred.
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.
1mo
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Quality Manager, US
Boston, Massachusetts, United States
$109k-$140k/yr OnsiteFull Time
Quality leadership in regulated environments; ISO 13485 and ISO 9001 knowledge; drive QMS improvements; capable of external audits and cross-functional collaboration.
eQMS
3mo
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Head of Safety, Quality & Regulatory- Oral Health Care
Bothell, Washington, United States
$181k-$289k/yr HybridFull Time
15+ YOE15+ years in product design/quality/regulatory with ISO 13485 and ISO 9001; experience in FDA Class I devices; leadership and budgeting experience.
1mo
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Quality Engineer Device Development (Deerfield Beach, FL, US)
Deerfield Beach, Florida, United States
OnsiteFull Time
2+ YOEBachelor's in science/engineering; 2+ years quality engineering; knowledge of ISO 13485, QSR, ISO 14971, IEC62366, IEC62304; cross-functional collaboration.
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
2mo
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Sr. Quality Systems/CAPA Engineer
Pleasanton, California, United States
$90k-$180k/yr OnsiteFull Time
5+ YOEBachelor’s in engineering; 5+ years engineering experience; knowledge of FDA 21 CFR 820, ISO 13485, ISO 14971; quality tools; CAPA and audits.
Quality tools, Statistical analysis, CAPA
1mo
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Operations Project Portfolio Manager
Largo, Florida, United States
OnsiteFull Time
7+ YOEBachelor's in Engineering/Operations/Life Sciences; 7+ years PM in regulated industry; knowledge of FDA Design Controls, ISO 13485, ISO 14971, and validation.
eQMS, PLM, ERP/MRP, Quality Management System
2mo
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Quality Manager
Tempe, Arizona, United States
OnsiteFull Time
7+ YOE1+ MgmtLead QA/QC across multiple sites; ensure ISO 13485 and ISO 9001 compliance; oversee transfers and QMS development; manage quality engineers and inspectors.
QMS, ISO 13485, ISO 9001
1w
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Quality Tech
Columbia City, Indiana, United States
OnsiteFull Time
Experience in manufacturing quality control, familiarity with ISO 13485/ISO 9001/FDA/CGMP/HACCP, instrument calibration, quality audits, data analysis, and quality systems.
Calypso, calipers, micrometers, vision inspection systems, coordinate measuring machines
2w
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Engineering Quality Manager
Brooksville, Florida, United States
OnsiteFull Time
Experience in medical-device quality engineering with knowledge of ISO 13485, ISO 9001, 21 CFR 820, SPC, PFMEA, validation, CAPA, and root cause analysis.
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