69 quality systems engineer jobs at 30 companies in Baldwin, WI
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Founding Backend / Infra Engineer
Cupertino, CA, US
$160k-$300k/yrOn-SiteFull Time
HiringCafe: Building a 100× better job search engine to take on Indeed and LinkedIn.
Own the crawlers, pipelines, and infrastructure powering a real-time job search engine. Strong Node.js and Python fundamentals; bonus points for security and reverse-engineering chops.
Arden Hills or Maple Grove or Marlborough or Clonmel or Cork or Galway
$85k-$162k/yrOnsiteFull Time
Boston ScientificNYSE: BSX: Developer and manufacturer of innovative medical devices and therapies.
5+ YOEBachelor's degree and 5+ years in quality engineering within a regulated industry; demonstrated CAPA and NCP experience; ability to own CAPAs end-to-end; strong problem-solving and Microsoft Office proficiency.
Arden Hills or Maple Grove or Marlborough or Clonmel or Cork or Galway
$85k-$162k/yrOnsiteFull Time
Boston ScientificNYSE: BSX: Manufacturer of interventional medical devices and technologies.
5+ YOEBachelor's degree and 5+ years in quality engineering within regulated industries; demonstrated CAPA and nonconforming product experience; ability to own CAPAs end-to-end; strong problem-solving and Microsoft Office proficiency.
Senior Quality Systems Engineer (Arden Hills, MN, US, 55112)
Arden Hills, Minnesota, United States
$85k-$162k/yrOnsiteFull Time
Boston ScientificNYSE: BSX: Developing and manufacturing innovative medical devices for less-invasive treatments.
5+ YOEBachelor's degree and 5+ years in quality or quality systems engineering in regulated industries; demonstrated CAPA/NCP experience, end-to-end CAPA ownership, strong problem-solving, and Microsoft Office proficiency.
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.
Parker HannifinNYSE: PH: Manufacturer of motion and control technologies and systems.
Bachelor's in engineering, experience with ISO 9001:2015 and quality engineering methods, familiarity with APQP/PPAP/MSA/SPC, Lean/Six Sigma, ERP/MRP and quality systems; ASQ/CQE/CQA or Six Sigma certification preferred.
ISO 9001:2015, APQP, PPAP, MSA, SPC, ERP/MRP, Lean Manufacturing, Six Sigma
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.
3MNYSE: MMM: Manufacturers diversified industrial, safety, consumer, and electronics products.
3+ YOEBachelor's degree, 3+ years combined quality engineering or related experience, familiarity with quality systems and statistical analysis, experience with supplier quality and manufacturing, ASQ certification preferred.
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
Lexington Manufacturing: Manufacturer of engineered wood components for windows and doors.
3+ YOEBachelor's degree or CQE, 3+ years quality experience in manufacturing, knowledge of ISO, SPC, auditing, APQP/PPAP, 8D/DMAIC, strong communication, and proficiency with Microsoft Office and ERP/SPC systems.
BaxterNew York Stock Exchange: BAX: Develops and manufactures medical devices, pharmaceuticals, and IV solutions.
5+ YOEBachelor's in science/engineering, 5+ years quality experience in medical device, audit experience, strong knowledge of FDA/ISO regulations (ISO 13485, 21 CFR 820), QMS expertise, communication, project management, and continuous improvement skills.
rms Company: Contract manufacturer of high-precision medical device components and implants.
Bachelor's in engineering, knowledge of quality systems and ISO, blueprint reading and GD&T, inspection equipment operation, data analysis, and proficiency with Microsoft Office.
Microsoft Outlook, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Publisher
Cirtec Medical: Outsourced design and manufacturing for complex medical devices.
5+ YOEBachelor's in a STEM engineering discipline, 5+ years relevant engineering experience, supplier quality experience, knowledge of CAPA, process validation, design controls, risk management, mechanical systems, tooling and manufacturing processes.
Cretex Medical: Manufactures precision components and assemblies for medical device companies.
10+ YOEBachelor’s in Mechanical/Industrial or related science; 10 years’ engineering in machining/manufacturing; knowledge of quality systems and regulatory standards; ERP and quality systems experience; strong communication; leadership; detail-oriented; MS Office proficiency.
ECI: Provides regulatory and engineering consulting for life sciences companies.
5+ YOEBachelor’s in Biomedical/Mechanical/Electrical engineering; 5+ years in medical device industry; strong communication and documentation; regulatory knowledge; Minitab; design controls.
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.