50 quality systems engineer jobs at 38 companies in Wales, WI
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Quality Systems Engineer
Janesville, Wisconsin, United States
$74k-$85k/yr OnsiteFull Time
Maintain and improve quality management system per IATF 16949/ISO 9001, lead audits, manage documentation, support corrective actions, and drive continuous improvement.
IMDS
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Quality Systems Manager
Milwaukee, Wisconsin, United States
OnsiteFull Time
7+ YOEBachelor’s degree in engineering, quality, or related field; seven years of quality systems experience; IATF 16949, ISO 9001, and AIAG expertise; audit leadership and strong analytical, communication, and leadership skills.
IATF 16949, ISO 9001, AIAG, APQP, PPAP, FMEA, SPC, MSA
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Quality Engineer
Whitewater, Wisconsin, United States
OnsiteFull Time
3+ YOERequires 3–5 years of quality experience, an Engineering or Business Operations degree, strong project management and problem-solving skills, and experience with quality systems, root cause analysis, and process improvement.
MiniTab, Design of Experiments (DOE), PDSA, A3, Microsoft Office, Microsoft Excel, Microsoft Access, Microsoft Power Automate, Microsoft SharePoint, macros
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Quality Engineer - Systems Assurance
Waukesha, Wisconsin, United States
OnsiteFull Time
7+ YOE7+ years medical device/biotech experience with CAPA and complaint handling; strong knowledge of FDA 21 CFR 820, ISO 13485, EU IVDR; RCA, risk management, eQMS experience; leadership and communication skills.
eQMS, TrackWise, MasterControl, SAP
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Quality Engineer (71099)
Waukesha, Wisconsin, United States
$86k-$126k/yr OnsiteFull Time
2+ YOEBachelor's degree and 2+ years of quality or manufacturing experience required, including 2+ years with quality management systems and internal audits. US work authorization without sponsorship required.
ISO 9001, PFMEA, APQP, PPAP, Lean Six Sigma
3d
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Quality Engineer Associate I
Franksville or Racine
OnsiteFull Time
Bachelor's degree or equivalent experience required. Preferred engineering or physical science degree, GLP/GMP and medical device experience, regulatory knowledge, quality systems expertise, laboratory skills, and LIMS or quality management software experience.
Nonconformance Records (NCR), Corrective and Preventive Action (CAPA), Change Control, Design History File (DHF), pFMEA, Laboratory Information Management Systems (LIMS), FDA, USP, EP, BP, ICH
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Operations Quality Engineer
Mequon, Wisconsin, United States
OnsiteFull Time
2+ YOEBachelor's degree; typically 2+ years quality engineering experience; legal work authorization in the U.S.; data analysis skills (Excel/Power BI); ISO documentation knowledge; experience with PCBA/Drive systems; SAP experience preferred.
Excel, Power BI, SAP, ISO documentation systems, PCB Assembly (PCBA), Drive systems
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Jr. Quality Engineer
Nashotah, Wisconsin, United States
OnsiteFull Time
5+ YOEBachelor's degree or equivalent; minimum 5 years quality system experience in manufacturing; experience with ISO 9001 / IATF 16949, PPAP, 8D, PFMEA; strong communication, problem-solving, and spreadsheet skills; occasional travel (<10%).
ISO 9001, IATF 16949, PPAP, 8D, 5 Why, PFMEA, process flow diagram
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Manufacturing Quality Engineer - Menomonee Falls, WI
Menomonee Falls, Wisconsin, United States
OnsiteFull Time
2+ YOEBachelor’s degree in quality engineering or related technical field, 2+ years in quality engineering or manufacturing, quality systems and statistical methods knowledge, Microsoft Office proficiency, and strong analytical skills.
Microsoft Office, CMM, APQP, PPAP, Measurement System Analysis (MSA), NADCAP, CASE, FAA
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Sr Assoc Quality Engineer - Mayville, WI
Mayville, Wisconsin, United States
OnsiteFull Time
1+ YOEBachelor's in quality, mechanical, or electrical engineering; 1+ years quality engineering in manufacturing; experience with ISO 9001:2015, capability and measurement systems analysis, statistical analysis, and procedure documentation.
2w
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Regulatory Quality Engineer
Kenosha or Elmhurst
OnsiteFull Time
5+ YOEEnsure regulatory and quality system compliance for medical devices, lead audits, manage validations, perform risk assessments, and support CAPA/MRB processes.
3d
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Senior Quality Engineer
Richfield, Wisconsin, United States
OnsiteFull Time
7+ YOERequires high school diploma or equivalent, 7–10 years of experience, QS/ISO system and auditing experience, ISO 13485 and FDA 21 CFR Parts 820 and 11 knowledge, and ISO Class 8 cleanroom experience.
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Supplier Quality Development Engineer
West Bend, Wisconsin, United States
OnsiteFull Time
5+ YOEBS in engineering,5+ years quality systems experience,ability to travel up to 50%,familiarity with APQP/FMEA/PPAP/MSA/SPC,experience auditing ISO 9001/TS16949 or VDA,problem-solving (8D/KT),Minitab proficiency.
Minitab
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Quality Assurance Engineer
Franklin, Wisconsin, United States
$70k-$120k/yr OnsiteFull Time
3+ YOEBachelor's in engineering or equivalent,3+ years QA/QC in sanitary process systems,knowledge of hygienic design,welding inspection,qualification/validation,DQ/OQ/IQ documentation and audit readiness.
P&IDs, 3D models, TIG, TIG orbital welding
2mo
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Quality Engineer
Woodstock, Illinois, United States
$70k/yr OnsiteFull Time
Develop and maintain quality systems, perform inspections and FAIs, lead root cause analysis and corrective actions, support APQP and SPC activities in a manufacturing environment.
APQP, Control Plan, PFMEA, Process Flow Diagram, Capability Studies, Gage R&R, SPC, IMDS, First Article Inspection (FAI), Dimensional Layout
2w
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QA Engineer
Carrollton, Wisconsin, United States
OnsiteFull Time
5+ YOEBachelor's degree in engineering and 5+ years of quality engineering experience in manufacturing. Requires ISO 13485, quality management systems, medical core tools, validation, statistics, communication, and problem-solving expertise.
Six Sigma, ISO 13485, ISO 9001, TL9000, PFMEA, Control Plans, SPC, MSA, FMEA
2mo
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Jr. Quality Engineer
Nashotah, Wisconsin, United States
OnsiteFull Time
5+ YOEBachelor's degree or equivalent, minimum 5 years quality system experience in manufacturing, ISO 9001/IATF 16949 knowledge, corrective action (8D, 5 why), PPAP, PFMEA, auditing, basic word processing and spreadsheet skills, occasional travel (<10%).
1w
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Quality Manager
Madison or West Bend or Yankton
$96k-$130k/yr OnsiteFull Time
5+ YOERequires 5+ years in quality assurance for commercial product manufacturing, quality system audit experience, and a bachelor's degree in engineering or applied science; knowledge of ISO/TS, TQM, Six Sigma, and LEAN.
ISO/TS, TQM, Six Sigma, LEAN
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Quality Associate II
Round Lake, Illinois, United States
$88k-$121k/yr OnsiteFull Time
3+ YOEBachelor's degree in a technical discipline and 3+ years in quality assurance, quality systems, quality engineering, or compliance in a regulated healthcare environment. Requires QMS, FDA, ISO 13485, cGMP, investigation, and documentation expertise.
TrackWise, Veeva, MasterControl, Electronic Quality Management System (eQMS), 5 Whys, Fishbone, Ishikawa, fault tree analysis, 21 CFR 210/211, 21 CFR Part 820, ISO 13485, cGMP
1w
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Supplier Quality Manager
Sun Prairie, Wisconsin, United States
OnsiteFull Time
7+ YOE3+ MgmtBachelor's degree in engineering, quality management, or related field; 7+ years of engineering or management experience, including 3+ years in supplier quality management; expertise in APQP, PPAP, audits, and quality systems.
APQP, PPAP, PFMEAs, Control Plans, Process Flows, MSA, GR&R, FMEAs, SCARs, Lean Six Sigma
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