94 quality systems engineer jobs at 62 companies in Smithfield, RI
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Sr. Quality Systems Engineer
Woburn, Massachusetts, United States
$94k-$119k/yrHybridFull Time
Sirtex Medical: Manufactures targeted radiation therapies for inoperable liver cancer patients.
5+ YOEBachelor's in engineering/life sciences required, 5+ years quality systems experience in medical device/pharma/biotech, proven eQMS administration (Veeva, MasterControl, ETQ, TrackWise), and strong knowledge of 21 CFR Part 820, ISO 13485, MDSAP.
Veeva Vault, MasterControl, ETQ, TrackWise, eQMS, Power BI, Tableau, Microsoft Excel
VulcanForms: Provides industrial-scale metal additive manufacturing and precision machining services.
3+ YOE3+ years in medical device or aerospace quality with knowledge of FDA requirements, ISO 13485/AS9100/ISO9001, QMS, CAPA, NCR, document control, procedure writing, audits, and quality metrics/KPIs.
Boston ScientificNYSE: BSX: Developer and manufacturer of innovative medical devices and therapies.
Bachelor's degree in engineering or a related technical field; quality engineering, process controls, CAPA, root cause analysis, data analysis, problem-solving, communication, and cross-functional collaboration skills required.
Boston ScientificNYSE: BSX: Manufacturer of interventional medical devices and technologies.
Bachelor's degree in engineering or a related technical field; quality engineering, process controls, CAPA, root cause analysis, continuous improvement, data analysis, communication, and cross-functional collaboration skills required.
Access Vascular: Develops biomaterial catheters that reduce clinical complications during intravenous therapy.
5+ YOEBachelor's in Engineering or Life Sciences; 5+ years quality systems in medical devices; QMS experience (FDA 21 CFR Part 820, ISO 13485); CAPA, document control, audits; CQE/CMDA or ISO Lead Auditor a plus.
TE ConnectivityNYSE: TEL: Manufacturer of electronic connectors and sensors for global industries.
5+ YOEBachelor's in engineering/science or related, 5+ years related experience, ISO 13485 knowledge, audit and CAPA experience, eQMS experience, strong investigation and communication skills.
Worthington EnterprisesNYSE: WOR: Manufactures pressure cylinders, steel products, and building materials.
3+ YOE3-5 years of quality engineering experience; knowledge of FMEA, internal audits, DOE, PPAP; skilled in statistics and quality systems; CQ Technician/Engineer or Auditor certifications preferred.
FMEA, Statistical software, MS Office, PPAP, DOE, Quality systems
Senior Systems Quality Engineer (Teradyne, N. Reading MA)
North Reading, Massachusetts, United States
$127k-$207k/yrOnsiteFull Time
TeradyneNASDAQ: TER: Designs and manufactures automated test equipment and advanced robotics systems.
10+ YOE10+ years in quality/systems/test engineering, bachelor's or master's in a technical discipline, strong system validation, automated test framework development, programming and CI/CD experience.
Principal Software Systems Quality Engineer onsite Tewksbury, MA
Tewksbury or Andover or Pelham or Marlborough
$108k-$205k/yrOnsiteFull Time
RTXNYSE: RTX: Provides advanced aerospace and defense systems and services.
8+ YOEU.S. citizenship and ability to obtain/maintain DoD Secret clearance; Bachelor’s in STEM and ~8 years quality/engineering experience; knowledge of Agile, testing, requirements, software lifecycle, metrics, and root cause analysis.
Windchill PDM, Azure DevOps, Azure DevOps Server, Business Insight, Jira, Microsoft Excel, Confluence, Jenkins, GitHub, Coverity, ClearCase, DOORS, RQM, Cameo, Rhapsody, Oracle, SAP, Microsoft PowerPoint
Analog DevicesNASDAQ: ADI: Designs and manufactures semiconductors for signal processing and power management.
Bachelor's degree in engineering, knowledge of medical device QMS (ISO 13485, FDA, EU MDR), experience with CAPA, audits, document control, training coordination, risk assessment, and proficiency with Microsoft Office and quality management software.
AcushnetNYSE: GOLF: Designs and manufactures high-performance golf products and apparel.
3+ YOEBachelor's in chemistry/engineering or related, 3+ years quality/manufacturing engineering, experience with quality systems, supplier qualification, testing procedures, root-cause analysis, and strong communication.
Integra LifeSciencesNASDAQ: IART: Manufacturing surgical instruments and regenerative medical technology devices.
8+ YOEBachelor’s degree in engineering or related field with 8+ years in quality engineering in regulated medical device/life sciences environments; experience with ISO 13485, ISO 14971, FDA QSR; strong background in FMEA, CAPA, and quality system procedures.
DFMEA, PFMEA, DoE, SPC, Quality Management System, ISO 13485, ISO 14971, FDA QSR
American Flowform & Machining: Precision metal forming and machining for demanding industrial applications.
3+ YOE3+ years manufacturing/aerospace quality experience preferred; support AS9100D QMS, lead root cause/CAPA, interpret drawings/GD&T, perform FAIRs, and use Microsoft Office and ERP/QMS systems. U.S. citizenship required.
AS9100D, GD&T, CMM, 5-Why, Fishbone, Process Mapping, Microsoft Outlook, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Visio, Microsoft Project
Nova Biomedical: Develops and manufactures blood testing analyzers and diagnostic equipment.
Expertise in ISO13485/ISO14971/MDSAP and 21CFR820, validation (IQ/OQ/PQ), PFMEA and risk analysis, data trending, internal auditing, and quality systems management.
Microsoft Word, Microsoft Excel, Microsoft Access, Minitab, Master Control, Power BI
NordsonNasdaq: NDSN: Manufactures precision dispensing and fluid management equipment for industry.
4+ YOEBachelor’s degree in Engineering; 4+ years QA/quality assurance experience; proficient in Microsoft Office; ISO 9001/quality systems experience; problem solving (root cause analysis); knowledge of QA tools (FMEA, DMAIC); able to read/interpret mechanical drawings.
Microsoft Office, Minitab, Six Sigma, FMEA, DMAIC, 8-D
Johnson & JohnsonNYSE: JNJ: Develops and manufactures pharmaceutical drugs and medical devices.
6+ YOEBachelor's degree in engineering or a related technical/scientific field and 6+ years of related experience. Requires NPD, process validation, GD&T, inspection, risk management, quality systems, and regulated-environment expertise.
GD&T, Quality Management Systems (QMS), Quality Control (QC), GxP, FDA, ISO
Johnson & JohnsonNYSE: JNJ: Global healthcare providing pharmaceuticals and medical technologies.
6+ YOEBachelor's degree in engineering or a related technical/scientific field and 6+ years of related experience. Requires NPD, process validation, GD&T, inspection, risk management, quality systems, and regulated-environment expertise.
Pramand: Develops implantable medical devices using proprietary hydrogel technology.
2+ YOE2+ years in regulated/controlled environments, bachelor’s in science or engineering (or equivalent), experience with quality systems, cGMP/ISO 13485/21CFR Part 820 familiarity, strong problem solving and communication.
Microsoft Excel, Microsoft PowerPoint, Microsoft Office
Foundation Medicine: Molecular profiling for personalized cancer treatment and research.
5+ YOE5+ years in quality systems or eQMS support, bachelor’s in related field or equivalent, experience with eQMS governance/validation, Veeva Vault preferred, strong technical writing and regulatory knowledge.
MedtronicNew York Stock Exchange: MDT: Develops and manufactures medical devices and digital health solutions.
3+ YOEAdvanced systems engineering experience in medical device imaging, leading cross-functional projects, system-level design, validation, and image quality optimization; advanced degree or extensive experience required.