135 quality assurance engineer jobs at 63 companies in Baldwin, WI
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Senior Quality Assurance Engineer
Maple Grove, Minnesota, United States
OnsiteFull Time
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.
NMDP: Operates the global marrow and blood stem cell registry.
10+ YOEBachelor's degree or equivalent experience; 10 years in IT/QA, 5 years in test automation and Agile development, automation leadership, programming, CI/CD, testing frameworks, and regulated-industry experience.
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 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.
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.
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.
Koch Inc.: Operates global manufacturing, refining, and industrial technology businesses.
1+ YOEBachelor’s degree in engineering, quality, life sciences, or related field, or 4+ years of quality/validation experience; 1+ year in regulated manufacturing. Medical device, FDA, ISO 13485, and validation experience preferred.
Microsoft Office, SAP, Kneat Gx, Minitab, GAMP5, FDA, ISO 13485, GMP
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
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.
Boston ScientificNYSE: BSX: Developing and manufacturing innovative medical devices for less-invasive treatments.
Boston Scientific quality engineering internship and a bachelor's degree in biomedical or industrial and systems engineering by spring 2027 are required; quality systems, medical devices, Microsoft Office, problem-solving, and data analysis experience are preferred.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Outlook, PFMEA, Gage R&R, Design of Experiment (DOE)
Boston ScientificNYSE: BSX: Developer and manufacturer of innovative medical devices and therapies.
2+ YOEBachelor's degree in engineering, science, or a related technical discipline and at least 2 years of engineering, quality, or related technical experience.
Heraeus: Global technology specializing in materials and medical components.
8+ YOEBachelor's in engineering, 8+ years relevant experience (or advanced degree substitution), medical device QMS experience, ISO 13485/FDA QSR familiarity, design controls, risk management, verification/validation, strong communication and mentoring skills.
Boston ScientificNYSE: BSX: Manufacturer of interventional medical devices and technologies.
3+ YOEBachelor’s degree in engineering, science, or related field and 3+ years’ relevant experience with process validation, verification, risk documentation, data analysis, and quality engineering.
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.
Tactile MedicalNasdaq: TCMD: Developing at-home medical devices for chronic disease therapy.
5+ YOE5+ years as Quality Engineer in medical devices; BS in Engineering. CQE/CQA/Six Sigma Belt preferred; strong knowledge of 21 CFR 820, ISO 13485, ISO 14971.
Statistical analysis tools, Documentation tools, CAPA and change management systems
Tri-Imaging Solutions: Provider of medical imaging parts, repair, and technical training.
6+ YOEBachelor's degree in engineering or related technical field and 6+ years of quality engineering experience in regulated manufacturing; medical device experience, plastic injection molding, validation, and compliance knowledge required.
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