121 quality systems engineer jobs at 76 companies in Marshfield, MA
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Quality Systems Engineer
Danvers, Massachusetts, United States
$79k-$128k/yrOnsiteFull Time
Johnson & JohnsonNYSE: JNJ: Provides pharmaceutical products and medical technology healthcare solutions.
3+ YOEBachelor's in engineering or quality management, 3+ years quality systems experience in a regulated industry, knowledge of ISO/FDA standards, strong analytical and communication skills; Six Sigma or CQE preferred.
Johnson & JohnsonNYSE: JNJ: Develops and manufactures pharmaceutical drugs and medical devices.
3+ YOEBachelor's in engineering/quality or related, 3+ years quality systems experience in a regulated industry, knowledge of ISO/FDA standards, Six Sigma/CQE preferred, strong analytical and communication skills.
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.
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.
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.
RTXNYSE: RTX: Provides advanced aerospace and defense systems and services.
2+ YOEBachelor's degree in STEM and 2 years of quality or engineering experience required. Requires U.S. citizenship, active Secret clearance, and experience with quality, software, testing, requirements, defects, releases, metrics, and analysis.
Curtiss-WrightNYSE: CW: Engineers and manufactures critical components for aerospace and defense.
4+ YOEBachelor's degree in engineering or a related technical field and 4–6+ years in quality assurance or manufacturing quality, with quality systems, inspection, corrective action, audit, and analytical expertise.
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.
SymboticNasdaq: SYM: AI-powered robotics and software for warehouse automation.
8+ YOEBachelor's degree in engineering and 8+ years in quality, electrical, reliability, or manufacturing engineering for complex manufactured products. Requires electrical systems expertise, quality methodologies, leadership, and advanced Excel.
APQP, DFMEA, PFMEA, Control Plans, PPAP, DOE, MSA, GR&R, SPC, 8D, Minitab, JMP, SAA, Microsoft Excel, PCBAs, ECUs
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.
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
TeleflexNYSE: TFX: Manufactures medical devices for critical care and surgical procedures.
6+ YOEBachelor’s degree in engineering or related technical field; 6+ years in quality or engineering in medical devices or regulated manufacturing; expertise in quality systems, design control, validation, risk management, investigations, and statistical methods.
FDA QSR (21 CFR 820), ISO 13485, EU MDR, MDSAP, DFMEA, PFMEA, 5 Why, Fishbone, DMAIC, PDCA
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