105 quality systems engineer jobs at 71 companies in Sutton, MA
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Quality Systems Engineer III
Indianapolis or Quincy or Plainfield
$82k-$156k/yrRemoteFull Time
Boston ScientificNYSE: BSX: Developing and manufacturing innovative medical devices for less-invasive treatments.
Requires a bachelor's degree in engineering or a related technical discipline, quality engineering and quality systems knowledge, data analysis, problem-solving, communication, and cross-functional collaboration.
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.
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
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.
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.
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.
Straumann GroupSIX Swiss Exchange: STMN: Global developer and manufacturer of dental replacement solutions.
5+ YOEBachelor’s degree in engineering, 5+ years engineering experience, strong knowledge of GMP and ISO, validation, statistical analysis, DOE, GR&R, and quality systems in medical device manufacturing.
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.
kSARIANYSE: ITT: Manufactures and installs mission-critical fiber optic and electrical connectivity solutions.
3+ YOEMaintain AS9100/ISO9001 quality system, perform audits, lead CAPA and root cause analysis, develop test programs, manage calibration and vendor performance; 3+ years quality engineering experience and bachelor's degree preferred.
Principal Software Systems Quality Engineer onsite Marlborough, MA
Marlborough or Tewksbury or Andover or Pelham
$108k-$205k/yrOnsiteFull Time
RTXNYSE: RTX: Provides advanced aerospace and defense systems and services.
8+ YOEU.S. citizen with active DoD Secret clearance, Bachelor’s in STEM and ~8 years quality/engineering experience; expertise in Agile, testing, requirements, software lifecycle, metrics, audits, and DevSecOps toolchains.
Windchill PDM, Azure DevOps, Azure DevOps Server, Confluence, Jenkins, GitHub, Coverity, Business Insight, Jira, Microsoft Excel, Microsoft PowerPoint, ClearCase, DOORS, RQM, Cameo, Rhapsody, Oracle, SAP
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
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
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
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.