81 quality systems engineer jobs at 41 companies in Cannon Falls, 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.
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
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.
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
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
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.
Cretex Companies: Contract manufacturer of precision medical device components and infrastructure products.
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
Seaway Plastics Engineering: Produces custom plastic injection molded parts and complex assemblies.
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
MME Group: Provider of custom plastic injection molding and contract manufacturing services.
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
DanaherNYSE: DHR: Develops scientific instruments and diagnostic tools for healthcare markets.
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.
JabilNYSE: JBL: Provides manufacturing and supply chain solutions for global brands.
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
JabilNYSE: JBL: Provider of comprehensive global manufacturing and supply chain solutions.
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 and communication skills.
Microsoft Office Suite, Microsoft Excel, Microsoft Word, Microsoft PowerPoint, SPC, MSA, 8D, 5 Whys, Fishbone diagrams, ISO 9001, ISO 13485, IATF 16949, Six Sigma
RTXNYSE: RTX: RTX provides advanced aerospace and defense systems and services.
2+ YOESTEM degree and minimum 2 years relevant experience, U.S. citizenship required, knowledge of quality systems (AS/EN9100, ISO-9001), APQP/8D and basic supplier quality and continuous improvement tools.
8D, root cause analysis, Apollo, APQP, Stride, PFMEA, Control Plans, Characteristic Matrix, Gage Capability, Process Capability, Process Flow, Value Stream Mapping, 5S, RCCA, PPAP, MPR
EPTAM Precision Solutions: Manufactures high-precision components for medical and aerospace markets.
1+ YOESupport and maintain QMS (ISO 13485, 21 CFR 820), manage CAPA/NC/RMA/MRB, execute IQ/OQ/PQ validations, develop inspection plans, use CMM/vision systems and hand gages; 1+ year QA experience; HS diploma required; STEM bachelor's preferred.