113 quality systems engineer jobs at 73 companies in Massachusetts
2d
Save
Mark Applied
Hide
2d
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: 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.
Genuine Parts CompanyNYSE: GPC: Global distributor of automotive and industrial replacement parts.
2+ YOEBachelor's in engineering or related field,2–5 years related experience,knowledge of mechanical design software,controls,vision,precision motion and robotics,project management and troubleshooting skills.
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.
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.
Rochester Electronics: Licensed semiconductor manufacturer and distributor for end-of-life components.
10+ YOE5+ MgmtBachelor's degree in engineering or related field, 10 years quality management experience, 5+ years supervisory experience, semiconductor manufacturing experience, knowledge of ISO9000/IATF16949/AS9100/JEDEC, SPC/LEAN/6 Sigma, auditing and strong computer and communication skills.
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
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
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
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