110 quality systems engineer jobs at 55 companies in New Brighton, MN
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Quality Systems Engineer
Shakopee, Minnesota, United States
$67k-$104k/yrOnsiteFull Time
Oatey: Manufacturer of plumbing parts, chemicals, and drainage solutions.
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.
Spectrum Plastics GroupNYSE: DD: Manufactures specialized medical device components and polymer-based solutions.
3+ YOEScience, Business, or similar degree; 3–5 years in quality assurance and manufacturing; ISO 13485:2016 or AS9100D:2016 knowledge; certified Lead Auditor; regulatory and customer audit experience.
Microsoft Word, Microsoft Excel, Microsoft Visio, Microsoft Access, Microsoft Outlook
Spectrum Plastics GroupNYSE: DD: Specialized manufacturer of medical device components and polymer solutions.
3+ YOEScience or business degree, 3–5 years of quality assurance experience in manufacturing, ISO 13485 and/or AS9100 knowledge, Lead Auditor certification, audit management experience, and proficiency with Microsoft Office tools.
Microsoft Word, Microsoft Excel, Microsoft Visio, Microsoft Access, Microsoft Outlook, ISO 13485:2016, AS9100D:2016
Boston ScientificNYSE: BSX: Developer and manufacturer of innovative medical devices and therapies.
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
Boston ScientificNYSE: BSX: Developing and manufacturing innovative medical devices for less-invasive treatments.
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
Boston ScientificNYSE: BSX: Manufacturer of interventional medical devices and technologies.
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
IntegerNYSE: ITGR: Manufactures medical devices and components for global healthcare companies.
0+ YOEBachelor's degree in engineering or related field; 0–3 years of experience; technical aptitude, independent and collaborative work ability, and written and oral communication skills.
Quality Management Systems (QMS), U.S. Food and Drug Administration (FDA), CAPA, NCR, 5S
STERISNYSE: STE: Provides infection prevention and procedural healthcare products and services.
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
Trystar: Designs and manufactures electrical power distribution and backup equipment.
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.
DiaSorinBorsa Italiana: DIA: Develops and manufactures in vitro diagnostic tests and laboratory equipment.
3+ YOEBachelor's degree in engineering, life sciences, or related field, or equivalent experience; 3+ years of quality engineering experience in medical devices or regulated industries; knowledge of quality systems, validation, audits, risk management, CAPA, and statistical methods.
Microsoft Word, Microsoft PowerPoint, Microsoft Excel, QMS software, PFMEA, SPC, DOE
nVentNYSE: NVT: Manufactures electrical connection and protection products for industrial systems.
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
Lake Air Products: A contract manufacturer serving medical, aerospace, defense, and industrial markets.
10+ YOE3+ Mgmt10+ years of progressive quality management experience in manufacturing; 3+ years in custom metals fabrication or contract manufacturing preferred; bachelor's degree in engineering, quality, manufacturing, or related field.
ISO 9001, ISO 13485, AS9100, CAPA, Lean/Six Sigma, ITAR, NADCAP
TSI: Manufactures precision measurement instruments for environmental and industrial monitoring.
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)
ProtolabsNYSE: PRLB: Manufactures custom prototypes and production parts using digital technologies.
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
3MNYSE: MMM: Manufacturers diversified industrial, safety, consumer, and electronics products.
3+ YOEBachelor's degree or higher and 3 years of combined quality engineering, manufacturing, or laboratory experience required. Preferred: master's degree, 5 years' quality or engineering experience, project management, analytics, auditing, and quality systems experience.
Koch Inc.: Operates global manufacturing, refining, and industrial technology businesses.
2+ YOELead product quality and validation for NPI and volume production; 2+ years manufacturing experience or Bachelor's/4+ years quality experience; knowledge of SPC/DOE, CAPA, audits, and quality systems.
SAP, SPC, Design of Experiment (DOE), AQP, FDA, ISO
TrelleborgNasdaq Stockholm: TREL B: Develops engineered polymer solutions to seal, damp, and protect.
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
DoverNYSE: DOV: Manufactures diversified industrial equipment and engineered components globally.
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.
Heraeus: Global technology specializing in materials and medical components.
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.
The Kinetic GroupEuronext Amsterdam: CSG: Manufactures and distributes small-caliber ammunition for global markets.
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