209 quality assurance engineer jobs at 89 companies in Andover, MN
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Software Quality Assurance Engineer II
Eden Prairie, Minnesota, United States
$79k-$107k/yrOnsiteFull Time
Starkey: Designs and manufactures advanced hearing aid technology.
5+ YOEBachelor's degree in computer science, software, electrical, or electronic engineering; 5+ years of software development or quality assurance; knowledge of software lifecycles, IEC 62304, and ISO 13485.
Microsoft Excel, IEC 62304, ISO 13485, 21 CFR Part 820, 21 CFR Part 11, FDA CSA, software simulators, electrical test equipment
Nextern: Designs and manufactures medical devices for healthcare partners.
3+ YOEBS in life sciences or equivalent; 5+ yrs in medical device quality or 3+ yrs in QA/Design Assurance; knowledge of 21 CFR 820 and ISO 13485; PLM tools; statistical software; strong communication.
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.
Principal Design Quality Assurance Engineer - Electrophysiology
Arden Hills, Minnesota, United States
$102k-$194k/yrHybridFull Time
Boston ScientificNYSE: BSX: Developing and manufacturing innovative medical devices for less-invasive treatments.
10+ YOEBachelor's degree in biomedical or electrical engineering, 10 years of medical device engineering experience, regulated-environment expertise, risk analysis, statistical methods, leadership, mentoring, and communication skills.
Medical Electrical Equipment (MEE), Medical Electrical Equipment/Systems (MEE / MES), single use device (SUD), Non-Conformance Reports (NCEP), Corrective and Preventive Actions (CAPA), Product Inquiry Report/Field Action Assessment (PIRs), Hazard Analysis, Fault Tree Analysis, Task and Use Error Analysis, Risk Management Plan, Risk Management Report, DFMEA, hardware, software, firmware, FDA, ISO, EUMDR, IEC 60601, EN ISO 14971, IEC 62304, EN ISO 13485
Principal Design Quality Assurance Engineer - Electrophysiology
Arden Hills, Minnesota, United States
$102k-$194k/yrHybridFull Time
Boston ScientificNYSE: BSX: Developer and manufacturer of innovative medical devices and therapies.
10+ YOEBachelor's degree in biomedical or electrical engineering, 10 years of medical device engineering experience, regulated-environment expertise, risk analysis, validation, statistical knowledge, leadership, communication, and mentoring skills.
Medical Electrical Equipment (MEE), single use device (SUD), Non-Conformance Reports (NCEP), Corrective and Preventive Actions (CAPA), Product Inquiry Report/Field Action Assessment (PIRs), Design Failure Mode and Effects Analysis (DFMEA), FDA, ISO, EUMDR, IEC 60601, EN ISO 14971, IEC 62304, EN ISO 13485
Principal Design Quality Assurance Engineer - Electrophysiology
Arden Hills, Minnesota, United States
$102k-$194k/yrHybridFull Time
Boston ScientificNYSE: BSX: Manufacturer of interventional medical devices and technologies.
10+ YOEBachelor's degree in biomedical or electrical engineering, 10 years of medical device engineering experience, regulated-environment expertise, design verification and validation knowledge, statistical skills, and strong leadership and communication abilities.
Medical Electrical Equipment (MEE), Single Use Device (SUD), Non-Conformance Reports (NCEP), Corrective and Preventive Actions (CAPA), Product Inquiry Report (PIR), Design Failure Modes and Effects Analysis (DFMEA), FDA, ISO, EUMDR, IEC 60601, EN ISO 14971, IEC 62304, EN ISO 13485
Endologix: Minimally invasive therapies for treating complex vascular diseases.
3+ YOEBachelor's degree in engineering, life sciences, or a related field; 3–5 years in medical device design quality assurance or related engineering; experience with design controls, risk management, V&V, and regulatory compliance.
Reviva: Remanufactures diesel and gas engines and engine components.
Bachelor's degree in engineering, quality management, or a related technical field, or equivalent experience; expertise in RCA, 8D, 5-Why, Ishikawa, engineering drawings, and quality KPI analysis.
Reviva: Remanufactures diesel and gas engines for industrial and fleet applications.
Bachelor’s degree in engineering, quality management, or a related technical field, or equivalent experience; expertise in root cause analysis, engineering drawings, standard work, and quality KPI analysis.
Heraeus: Global technology group providing precious metals and medical products.
8+ YOEBachelor in engineering (Master preferred),8+ years relevant experience,medical device quality experience,knowledge of ISO 13485/FDA QSR/design controls/risk management,inspection and root‑cause skills,Microsoft Word/Excel and Minitab proficiency.
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
Trane TechnologiesNYSE: TT: Global provider of heating, ventilation, and air conditioning solutions.
3+ YOEBachelor's degree in engineering preferred, or equivalent experience; 3–5 years of manufacturing quality engineering experience; knowledge of Lean, QMS, Six Sigma, DFMEA, PFMEA, PPAP, and APQP.
Microsoft PowerPoint, Microsoft Excel, Microsoft Teams, Lean, Quality Management System (QMS), 5 Whys, Pareto Analysis, Six Sigma, DFMEA, PFMEA, PPAP, APQP
HistoSonics: Develops non-invasive sonic beam therapy for destroying targeted tumors.
5+ YOEBachelor's degree in engineering or a related technical field; 5+ years of quality engineering experience, ideally in medical devices or regulated manufacturing; experience with risk, complaints, statistics, and quality standards.
PFMEA, FDA 21 CFR Part 820, ISO 13485, ISO 14971, Device History Records (DHR), CAPA
The Malco Group: Manufacturer of professional HVACR tools and building construction solutions.
5+ YOEBachelor's in engineering or quality (or equivalent experience), minimum 5 years manufacturing/supplier quality, strong knowledge of APQP/FMEA/MSA/SPC/PPAP, ISO and 8D problem solving, audit experience, Microsoft Office proficiency.
UnitedHealth GroupNYSE: UNH: Provides health insurance and technology-enabled health care services.
5+ YOERequires 5+ years in software testing or quality engineering, automation, performance and API testing, Agile/Scrum experience, and 2+ years coordinating testing across applications.
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
Computype: Provides industrial and healthcare track and trace labeling solutions.
2+ YOE2+ years quality experience; bachelor’s in a technical field preferred; working knowledge of ISO 9001; root cause analysis, engineering drawing interpretation, and multi-project management skills.
TrelleborgNasdaq Stockholm: TREL B: Manufactures polymer-based solutions for sealing, damping, and protecting applications.
2+ YOEBachelor's degree in quality, engineering, or related field; 2+ years in manufacturing technical support. ASQ quality engineering, Six Sigma, GMP, ISO, FDA, EU/MDR, and ITAR knowledge preferred.
Process Failure Modes and Effects Analysis (pFMEA), Gage Repeatability and Reproducibility (GRR), Design of Experiments (DOE), ANOVA, Capability Analysis, Microsoft
Beacon EmbeddedWorksLondon Stock Exchange: DSCV: Manufacturer of customized System on Module embedded computing solutions.
3+ YOEBachelor's degree in engineering or related field, 3-5 years of manufacturing experience, 2-3 years in electronics manufacturing, SMT experience, quantitative quality methods, problem-solving, and Microsoft Office proficiency.