Senior Quality Systems Engineer - Bolt Integration
Maple Grove, Minnesota, United States
$85k-$162k/yrHybridFull Time
Boston ScientificNYSE: BSX: Developing and manufacturing innovative medical devices for less-invasive treatments.
5+ YOEBachelor's degree,5+ years quality systems experience in regulated industry,knowledge of ISO 13485/21 CFR Part 820/EU MDR,experience with audits,CAPA,and cross-functional quality system integration.
Senior Quality Systems Engineer - Bolt Integration
Arden Hills or Maple Grove
$85k-$162k/yrHybridFull Time
Boston ScientificNYSE: BSX: Developer and manufacturer of innovative medical devices and therapies.
5+ YOEBachelor's in engineering/quality/life sciences,5+ years quality systems experience in a regulated industry,knowledge of ISO 13485/21 CFR Part 820/EU MDR,experience with audits,CAPA and integration;able to travel up to 25%.
Senior Quality Systems Engineer - Bolt Integration
Maple Grove or Arden Hills
$85k-$162k/yrHybridFull Time
Boston ScientificNYSE: BSX: Manufacturer of interventional medical devices and technologies.
5+ YOEBachelor's in engineering/quality/life sciences,5+ years quality systems experience in regulated industry,knowledge of ISO 13485,21 CFR Part 820 and EU MDR,experience with audits,CAPA and integration projects,ability to travel up to 25%.
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.
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.
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.
rms Company: Manufactures precision medical implants and components for medical OEMs.
Bachelor's in engineering, knowledge of quality systems, GD&T, inspection equipment, data analysis, and Microsoft Office; ability to support audits and validation activities.
Microsoft Outlook, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Publisher
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.
RTXNYSE: RTX: RTX provides advanced aerospace and defense systems and services.
5+ YOEDegree in STEM with 5+ years relevant experience (or advanced degree with 3+ years). Experience in manufacturing, APQP, PPAP, RCCA, 8D, continuous improvement, and quality system standards.
APQP, AS9145, AS13100, 8D, RCCA, PPAP, MPR, ETQP, Stride, PFMEA, Control Plan, Gage Capability, Process Capability, AS/EN9100, ISO-9001
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.
AbbottNYSE: ABT: Manufactures medical devices, diagnostics, and nutritional health products.
2+ YOEBachelors in related field or equivalent, 2+ years related experience (2-5 years typical), working knowledge of quality systems, supplier/component quality, ability to develop inspection procedures, analyze defects, and mentor junior staff.
AbbottNYSE: ABT: Provides medical devices, diagnostics, and science-based nutritional products.
2+ YOEBachelor's degree or equivalent, 2+ years related experience, working knowledge of quality systems and supplier quality processes, ability to assess suppliers, develop inspection procedures, analyze defects, and drive corrective action.
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.