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Quality Systems Engineer
Salem, New Hampshire, United States
OnsiteFull Time
8+ YOEMaintain and improve QMS, lead internal/external audits, assess risks, drive corrective actions; Bachelor's degree in engineering/quality/manufacturing or related; 8+ years experience (6+ with Master's); proficiency with Microsoft Office and quality software.
Microsoft Office
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Quality Systems Engineer
Devens, Massachusetts, United States
$75k-$104k/yr OnsiteFull Time
3+ YOE3+ years in medical device or aerospace quality with knowledge of FDA requirements, ISO 13485/AS9100/ISO9001, QMS, CAPA, NCR, document control, procedure writing, audits, and quality metrics/KPIs.
1mo
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Sr. Quality Systems Engineer
Woburn, Massachusetts, United States
$94k-$119k/yr HybridFull Time
5+ YOEBachelor's in engineering/life sciences required, 5+ years quality systems experience in medical device/pharma/biotech, proven eQMS administration (Veeva, MasterControl, ETQ, TrackWise), and strong knowledge of 21 CFR Part 820, ISO 13485, MDSAP.
Veeva Vault, MasterControl, ETQ, TrackWise, eQMS, Power BI, Tableau, Microsoft Excel
3w
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Senior Quality Systems Engineer
Medway, Massachusetts, United States
$93k-$116k/yr OnsiteFull Time
5+ YOEBachelor's degree in engineering/science/quality, 5+ years related experience, ISO 13485 knowledge, audit and CAPA experience, eQMS experience, strong problem-solving and communication skills.
electronic Quality Management Systems (eQMS)
2mo
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Senior Quality Systems Engineer
Billerica, Massachusetts, United States
$93k-$160k/yr OnsiteFull Time
5+ YOEBachelor's in Engineering or Life Sciences; 5+ years quality systems in medical devices; QMS experience (FDA 21 CFR Part 820, ISO 13485); CAPA, document control, audits; CQE/CMDA or ISO Lead Auditor a plus.
Greenlight Guru, MasterControl, ETQ, eQMS platforms
1w
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Quality Systems Engineer
Danvers, Massachusetts, United States
$85k-$117k/yr OnsiteFull Time
2+ YOEBachelor's in engineering or related field,2–5 years related experience,knowledge of mechanical design software,controls,vision,precision motion and robotics,project management and troubleshooting skills.
mechanical design software, machine controls, vision systems, precision motion control, robotics
3w
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Senior Quality Systems Engineer
Medway, Massachusetts, United States
$93k-$116k/yr OnsiteFull Time
5+ YOEBachelor's in engineering/science or related, 5+ years related experience, ISO 13485 knowledge, audit and CAPA experience, eQMS experience, strong investigation and communication skills.
eQMS
3w
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Senior Systems Quality Engineer (Teradyne, N. Reading MA)
North Reading, Massachusetts, United States
$127k-$207k/yr OnsiteFull Time
10+ YOE10+ years in quality/systems/test engineering, bachelor's or master's in a technical discipline, strong system validation, automated test framework development, programming and CI/CD experience.
C#, C++, Python, PowerShell, Bash, Windows, Linux, Jenkins, GitLab CI, Jira
1mo
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Quality Systems Engineer – CAPA and Process Improvement
Manchester, New Hampshire, United States
OnsiteFull Time
3+ YOEBS/MS in engineering, life sciences, or related field; 3+ years in quality systems in a regulated industry (medical device preferred); working knowledge of FDA QSR (21 CFR Part 820) and ISO 13485; strong technical writing and communication; proficiency with Microsoft Excel, Word, and Visio.
Microsoft Excel, Microsoft Word, Microsoft Visio
3w
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Principal Software Systems Quality Engineer onsite Tewksbury, MA
Tewksbury or Andover or Pelham or Marlborough
$108k-$205k/yr OnsiteFull Time
8+ YOEU.S. citizenship and ability to obtain/maintain DoD Secret clearance; Bachelor’s in STEM and ~8 years quality/engineering experience; knowledge of Agile, testing, requirements, software lifecycle, metrics, and root cause analysis.
Windchill PDM, Azure DevOps, Azure DevOps Server, Business Insight, Jira, Microsoft Excel, Confluence, Jenkins, GitHub, Coverity, ClearCase, DOORS, RQM, Cameo, Rhapsody, Oracle, SAP, Microsoft PowerPoint
2mo
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Sr. Quality Engineer
Lowell, Massachusetts, United States
$100k-$130k/yr OnsiteFull Time
5+ YOEBachelor’s degree in STEM with 5 years of quality engineering experience; knowledge of QA systems, statistics, CAPA, and GMP.
Minitab, Microsoft Excel, Microsoft Office
3w
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Senior Principal Quality Engineer – Design Quality & Systems Excellence
Danvers, Massachusetts, United States
$122k-$213k/yr HybridFull Time
12+ YOEBachelor’s in engineering, 12+ years medical device quality engineering experience, expertise in design controls, risk management (ISO 14971), IEC 60601, FMEA, usability (IEC 62366), ISO 13485, and advanced statistical reliability methods.
3w
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Senior Principal Quality Engineer – Design Quality & Systems Excellence
Danvers, Massachusetts, United States
$122k-$213k/yr HybridFull Time
12+ YOE12+ years in medical device development and quality engineering, Bachelor's/Master's in Engineering, expertise in design controls, risk management (ISO 14971), IEC 60601, FMEA, human factors (IEC 62366), ISO 13485, and advanced statistical/reliability methods.
1mo
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Engineer, Quality Engineering
Wilmington, Massachusetts, United States
$75k-$103k/yr OnsiteFull Time
Bachelor's degree in engineering, knowledge of medical device QMS (ISO 13485, FDA, EU MDR), experience with CAPA, audits, document control, training coordination, risk assessment, and proficiency with Microsoft Office and quality management software.
Microsoft Office Suite, Six Sigma, Lean
1mo
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Manager, Quality Systems
Newburyport, Massachusetts, United States
$179k-$180k/yr OnsiteFull Time
10+ YOE5+ MgmtBachelor's degree in engineering or related field, 10 years quality management experience, 5+ years supervisory experience, semiconductor manufacturing experience, knowledge of ISO9000/IATF16949/AS9100/JEDEC, SPC/LEAN/6 Sigma, auditing and strong computer and communication skills.
SPC, LEAN, 6 Sigma, ISO9000, IATF16949, MIL-PRF-38535, AS9100, JEDEC
3w
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Quality Engineer
Hudson, New Hampshire, United States
OnsiteFull Time
3+ YOEMaintain AS9100/ISO9001 quality system, perform audits, lead CAPA and root cause analysis, develop test programs, manage calibration and vendor performance; 3+ years quality engineering experience and bachelor's degree preferred.
Microsoft Office
2mo
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Staff Quality Engineer
Braintree, Massachusetts, United States
$109k-$150k/yr OnsiteFull Time
8+ YOEBachelor’s degree in engineering or related field with 8+ years in quality engineering in regulated medical device/life sciences environments; experience with ISO 13485, ISO 14971, FDA QSR; strong background in FMEA, CAPA, and quality system procedures.
DFMEA, PFMEA, DoE, SPC, Quality Management System, ISO 13485, ISO 14971, FDA QSR
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Quality Engineer
Billerica, Massachusetts, United States
OnsiteFull Time
3+ YOE3+ years manufacturing/aerospace quality experience preferred; support AS9100D QMS, lead root cause/CAPA, interpret drawings/GD&T, perform FAIRs, and use Microsoft Office and ERP/QMS systems. U.S. citizenship required.
AS9100D, GD&T, CMM, 5-Why, Fishbone, Process Mapping, Microsoft Outlook, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Visio, Microsoft Project
3d
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Quality Engineer II
Salem, New Hampshire, United States
OnsiteFull Time
Knowledge of medical device quality systems (ISO 13485, 21 CFR 820), GMP/GDP, CAPA, SPC, root-cause analysis, gage R&R, supplier quality (SCAR, MRB), process and transfer validations, and internal auditing.
ISO 13485, 21CFR Part 820, GMP, GDP, SPC, SCAR, gage R&R
1w
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Defense Operations Quality Systems Leader
Lynn, Massachusetts, United States
$182k-$243k/yr OnsiteFull Time
5+ YOEEstablish and lead defense quality and safety management systems, ensure regulatory compliance, lead audits and CAPA, develop teams; requires quality/engineering/manufacturing experience and QMS expertise.
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