116 quality systems engineer jobs at 74 companies in Gardner, MA
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Quality Systems Engineer
United States or Mexico or Northborough
$95k-$120k/yr RemoteFull Time
5+ YOEBachelor’s degree in a relevant technical field, 5+ years of quality management system experience, IATF 16949 lead auditor qualification, automotive core tools knowledge, audit coordination, problem-solving, and willingness to travel internationally.
ISO 9001, IATF 16949, VDA 6.3, APQP, PPAP, FMEA, Control Plan, SPC, MSA, DMAIC, 8D, 5 Whys, Fishbone Diagrams, DFMEA, PFMEA, DOE, Electronic Medical Records (EMR)
2mo
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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.
3mo
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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
6d
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Quality Systems Engineer - Injection Molding
Lancaster, Massachusetts, United States
$85k-$95k/yr OnsiteFull Time
3+ YOEThree years of progressive manufacturing or quality experience in FDA and ISO 13485 environments, with QMS and operations knowledge. A bachelor's degree in engineering or a relevant STEM field is preferred.
Quality Management System (QMS), CAPA, Six-Sigma, Poka-Yoke, Measurement System Analysis
1w
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Corporate Quality Systems Engineer
United States or Mexico or Northborough
$95k-$120k/yr RemoteFull Time
Bachelor’s degree preferred in a relevant technical field; 5+ years of quality management experience in automotive, chemical, or manufacturing; IATF 16949 lead auditor qualification and Automotive Core Tools expertise required.
ISO 9001, IATF 16949, VDA 6.3, 8D, 5 Whys, Fishbone Diagrams, DMAIC, APQP, PPAP, FMEA, Control Plan, SPC, MSA, DFMEA, PFMEA, DOE
1mo
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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
6d
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Quality Systems Engineer – CAPA and Process Improvement
Manchester, New Hampshire, United States
OnsiteFull Time
3+ YOERequires a BS/MS in engineering or life sciences, 3+ years in quality systems in a regulated industry, FDA 21 CFR Part 820 and ISO 13485 knowledge, and proficiency with Microsoft Office tools.
Microsoft Excel, Microsoft Word, Microsoft Visio
1mo
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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
2w
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Software Systems Quality Engineer - Tewksbury, MA
Tewksbury or Andover or Pelham or Marlborough
$69k-$131k/yr OnsiteFull Time
2+ YOEBachelor's degree in STEM and 2 years of quality or engineering experience required. Requires U.S. citizenship, active Secret clearance, and experience with quality, software, testing, requirements, defects, releases, metrics, and analysis.
Windchill PDM, Azure DevOps, Microsoft Excel, PowerPoint, Confluence, Azure DevOps Server, Jenkins, GitHub, Coverity, Integrated Development Environment (IDE), ClearCase, DOORS, RQM, Cameo, Rhapsody, Oracle, SAP, LAN, WAN, VPN, OSI, TCP, IP, IPsec, TLS, DHCP, SNMP, FC, SCSI, DNS, IDS, SIEM
2w
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Quality Engineer
Hauppauge or Tewksbury
$84k-$90k/yr OnsiteFull Time
4+ YOEBachelor's degree in engineering or a related technical field and 4–6+ years in quality assurance or manufacturing quality, with quality systems, inspection, corrective action, audit, and analytical expertise.
GLP, GMP, ISO, Six Sigma
3mo
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Quality Engineer
Andover, Massachusetts, United States
$108k-$133k/yr OnsiteFull Time
5+ YOEBachelor’s degree in engineering, 5+ years engineering experience, strong knowledge of GMP and ISO, validation, statistical analysis, DOE, GR&R, and quality systems in medical device manufacturing.
SAP, PLM
2mo
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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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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
2d
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Quality Engineer III
Hudson, New Hampshire, United States
$84k-$168k/yr OnsiteFull Time
4+ YOEBachelor's degree in engineering and 4–6 years of manufacturing, operations project management, or quality experience with complex electromechanical systems. Requires AS9100, AS9102, IPC, root-cause, corrective-action, and quality-process expertise.
Product Lifecycle Management, Agile, ERP, Oracle, Manufacturing Execution System, Factory Logix, Jira, Confluence, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Outlook, Microsoft Teams, LinkedIn Learning, Headspace, Aaptiv, Virgin Pulse
2w
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Staff Quality Engineer - Electrical
Wilmington, Massachusetts, United States
$125k-$172k/yr HybridFull Time
8+ YOEBachelor's degree in engineering and 8+ years in quality, electrical, reliability, or manufacturing engineering for complex manufactured products. Requires electrical systems expertise, quality methodologies, leadership, and advanced Excel.
APQP, DFMEA, PFMEA, Control Plans, PPAP, DOE, MSA, GR&R, SPC, 8D, Minitab, JMP, SAA, Microsoft Excel, PCBAs, ECUs
2mo
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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
3w
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Quality Engineer II
Bedford, Massachusetts, United States
$77k-$100k/yr OnsiteFull Time
2+ YOE2+ years in regulated/controlled environments, bachelor’s in science or engineering (or equivalent), experience with quality systems, cGMP/ISO 13485/21CFR Part 820 familiarity, strong problem solving and communication.
Microsoft Excel, Microsoft PowerPoint, Microsoft Office
4w
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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
2mo
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Senior Quality Engineer
Billerica, Massachusetts, United States
$125k-$135k/yr HybridFull Time
Expertise in ISO13485/ISO14971/MDSAP and 21CFR820, validation (IQ/OQ/PQ), PFMEA and risk analysis, data trending, internal auditing, and quality systems management.
Microsoft Word, Microsoft Excel, Microsoft Access, Minitab, Master Control, Power BI
1mo
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Sr Quality Engineer
Andover, Massachusetts, United States
$105k-$130k/yr OnsiteFull Time
5+ YOE5+ years product quality engineering in semiconductor/electronics manufacturing; strong knowledge of ISO 9001:2015 and IATF16949; Six Sigma Black Belt or CQE; statistics with JMP or Minitab; experience with PLM systems; BSEE or BSME required.
JMP, Minitab, Omnify, Agile, Matrix One, Microsoft Project, Visio
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