78 quality systems engineer jobs at 42 companies in Monticello, MN
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Quality Systems Engineer
Shakopee, Minnesota, United States
$67k-$104k/yr OnsiteFull Time
3+ YOERequires 3–5 years of QMS auditing experience in manufacturing, quality standards and audit expertise, analytical and communication skills, and problem-solving ability. Engineering or operations bachelor's degree preferred or equivalent experience.
ISO 9001
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Senior Quality Systems Engineer
Arden Hills, Minnesota, United States
$85k-$162k/yr HybridFull Time
5+ YOEBachelor's degree plus 5 years or master's degree plus 3 years; experience leading complex quality system projects, CAPA, audits, regulatory inspections, and medical device compliance.
Corrective and Preventive Action (CAPA), 21 CFR Part 820, Quality Management System Regulation (QMSR), ISO 13485, EU MDR, MDSAP, ISO 14971
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Senior Quality Systems Engineer
Arden Hills, Minnesota, United States
$85k-$162k/yr HybridFull Time
3+ YOEBachelor's degree in a technical discipline with 5+ years' experience or master's degree with 3+ years; quality systems, CAPA, audits, medical device regulations, project management, and cross-functional leadership experience.
21 CFR Part 820, Quality Management System Regulation (QMSR), ISO 13485, EU MDR, MDSAP, ISO 14971
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Senior Quality Systems Engineer
Arden Hills, Minnesota, United States
$85k-$162k/yr HybridFull Time
5+ YOEBachelor's degree plus 5 years or master's degree plus 3 years of experience; requires quality systems, medical device regulations, CAPA, audits, project management, and cross-functional leadership expertise.
Corrective and Preventive Action (CAPA), 21 CFR Part 820, Quality Management System Regulation (QMSR), ISO 13485, EU MDR, MDSAP, ISO 14971
3d
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Manager, Quality Systems (55670)
Coon Rapids, Minnesota, United States
$115k-$130k/yr OnsiteFull Time
10+ YOE2+ MgmtBachelor’s degree in a scientific or technical field; 10+ years of manufacturing, quality engineering, or quality systems experience; 10+ years in an ISO-certified environment; and 2+ years in quality leadership.
Microsoft Excel, Microsoft Word, Microsoft PowerPoint, TrackWise
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Quality Systems Specialist
Faribault or Burnsville
$70k-$80k/yr OnsiteFull Time
3+ YOE3+ years in quality systems/assurance/engineering in manufacturing, working knowledge of ISO 9001, QMS administration (ETQ preferred), audit and CAPA support, Microsoft 365 proficiency, strong communication and attention to detail.
ETQ, Microsoft 365, Epicor
3d
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Quality Engineer
Anoka, Minnesota, United States
$76k-$141k/yr OnsiteFull Time
2+ YOEBachelor's degree required, preferably in engineering, plus 2+ years in manufacturing or quality. Requires quality systems, Lean, Six Sigma, continuous improvement, and cross-functional problem-solving experience.
Six Sigma, Advanced Product Quality Planning (APQP), FMEA, Control Plans, SPC, FAI, PPAP, ISO 9001
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Quality Systems Supervisor
Shoreview, Minnesota, United States
$90k-$105k/yr OnsiteFull Time
5+ YOE1+ MgmtBachelor's degree in quality, engineering, science, business, or related field; 5+ years in quality functions; 1+ year supervisory or leadership experience; QMS, audits, CAPA, and regulated-environment experience.
Microsoft Office, Quality Management System (QMS), ISO 9001, ISO 17025, Corrective and Preventive Action (CAPA), Measurement and Test Equipment (M&TE)
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Sr Quality Engineer
Plymouth, Minnesota, United States
$100k-$133k/yr OnsiteFull Time
7+ YOEBachelor's degree in engineering, physical science, or related field; 7+ years as a quality engineer in manufacturing; quality systems, ISO standards, continuous improvement, statistical analysis, and fluent English.
JMP, Minitab, CMM, VMM, R&R, MSA, CNC, DMAIC, 8D, ISO 9001, ISO 13485, AS9100
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NPD Quality Engineer
Delano, Minnesota, United States
$78k-$97k/yr OnsiteFull Time
2+ YOERequires a 4-year degree in quality, engineering, or a related field and 2+ years in a manufacturing technical support role; knowledge of medical device quality systems and validation is required.
ISO 13485, ISO 9000, ISO 9001, FDA 21 CFR 820, FDA 21 CFR 11, EU/MDR, ITAR, Process Failure Modes and Effects Analysis (pFMEA), Gage Repeatability and Reproducibility (GRR), Measurement System Analysis (MSA), DOE, ANOVA, CAPAs, IQ/OQ/PQ
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Senior Quality Engineer
Roseville, Minnesota, United States
$105k-$120k/yr OnsiteFull Time
10+ YOEBachelor's in Engineering, 10+ years in quality or manufacturing, proficiency with ISO 13485/9001 and quality systems, strong problem-solving and communication skills, ability to perform root cause analysis and CAPA.
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Quality Engineer III
White Bear Lake or Saint Paul
$100k-$117k/yr OnsiteFull Time
5+ YOEBachelor's degree in engineering preferred, 5+ years relevant experience required, and expertise in quality systems, statistical analysis, validation, nonconformance, audits, and medical device manufacturing.
MRP, ERP, Minitab, SPC, Six Sigma, GD&T
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Quality Engineer II
Brooklyn Park, Minnesota, United States
$75k-$113k/yr OnsiteFull Time
3+ YOEBachelor's in engineering, 3+ years manufacturing engineering experience, knowledge of quality systems and regulatory requirements, blueprint reading and GD&T, inspection equipment operation, DOE and capability studies, ERP and Microsoft Office proficiency.
Minitab, ERP, Microsoft Outlook, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Publisher
2d
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Quality Engineer - Federal Ammunition
Anoka, Minnesota, United States
$67k-$94k/yr OnsiteFull Time
1+ YOEBachelor's degree in industrial or mechanical engineering, 1–3 years of quality engineering experience in high-volume consumer manufacturing, and knowledge of SPC, DOE, TQM, quality systems, and statistical analysis.
Statistical Process Control (SPC), Design of Experiments (DOE), Total Quality Management (TQM), Six Sigma, ISO 9000
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Indirect Labor - Quality - Quality Engineer
Vadnais Heights, Minnesota, United States
OnsiteFull Time
4+ YOEB.S. in Engineering or equivalent experience, 4+ years in regulated manufacturing, IQ/OQ/PQ validation, ISO 13485 and FDA quality system knowledge, audit support, root cause analysis, GD&T, Epicor experience preferred.
Epicor, ISO 13485, GD&T, Lean, Six Sigma, 8D, DMAIC, A3, IQ, OQ, PQ, CAPA, SCAR, RMA, NCR, MRB
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Indirect Labor - Quality - Quality Engineer
Vadnais Heights, Minnesota, United States
OnsiteFull Time
4+ YOEB.S. in Engineering or equivalent, 4+ years in regulated manufacturing, experience with IQ/OQ/PQ validation, ISO 13485 and FDA quality systems, root cause analysis, print reading, cGMP/cGDP, GD&T, ERP (Epicor) experience preferred.
Epicor, ERP, Lean, Six Sigma, DMAIC, 8D, A3, IQ, OQ, PQ, ISO 13485, cGMP, cGDP, GD&T, CAPA
3w
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Staff Quality Assurance-Supplier Quality Engineer
Chaska, Minnesota, United States
$140k-$160k/yr OnsiteFull Time
7+ YOEBachelor's or Master's in a technical field with extensive quality/supplier quality experience, 7+ years in quality engineering, knowledge of quality systems, risk management, CAPA, statistical methods, strong communication, and up to 15% travel.
ISO 13485, Danaher Business System
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Quality Engineer
Coon Rapids, Minnesota, United States
$75k-$90k/yr OnsiteFull Time
3+ YOEBachelor's degree or CQE, 3+ years quality experience in manufacturing, knowledge of ISO, SPC, auditing, APQP/PPAP, 8D/DMAIC, strong communication, and proficiency with Microsoft Office and ERP/SPC systems.
8D, APQP, PPAP, DMAIC, Microsoft Office, ERP, SPC
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Additive (3D Printing) Quality Engineer
Coon Rapids, Minnesota, United States
$68k-$113k/yr OnsiteFull Time
Bachelor's in engineering, knowledge of quality systems, GD&T, inspection equipment, data analysis, and Microsoft Office; ability to support audits and validation activities.
Microsoft Outlook, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Publisher
3d
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Quality Engineer II- Medical Devices
Maple Grove, Minnesota, United States
$69k-$124k/yr OnsiteFull Time
2+ YOEBachelor's degree in engineering and 2+ years in regulated quality manufacturing. Requires quality systems, SPC, MSA, root cause analysis, Microsoft Office, technical drawings, and strong analytical skills.
Microsoft Office Suite, Microsoft Excel, Microsoft Word, Microsoft PowerPoint, SPC, MSA, 8D, Six Sigma
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