118 quality systems engineer jobs at 74 companies in Worcester, MA
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Quality Systems Engineer
Salem, New Hampshire, United States
OnsiteFull Time
TTM TechnologiesNASDAQ: TTMI: Manufactures printed circuit boards and radio frequency technology solutions.
8+ YOEMaintain and improve QMS, lead internal/external audits, assess risks, drive corrective actions; Bachelor's degree in engineering/quality/manufacturing or related; 8+ years experience (6+ with Master's); proficiency with Microsoft Office and quality software.
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
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.
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
Senior Principal Quality Engineer – Design Quality & Systems Excellence
Danvers, Massachusetts, United States
$122k-$213k/yrHybridFull Time
Johnson & JohnsonNYSE: JNJ: Develops and manufactures pharmaceutical drugs and medical devices.
12+ YOEBachelor’s in engineering, 12+ years medical device quality engineering experience, expertise in design controls, risk management (ISO 14971), IEC 60601, FMEA, usability (IEC 62366), ISO 13485, and advanced statistical reliability methods.
Senior Principal Quality Engineer – Design Quality & Systems Excellence
Danvers, Massachusetts, United States
$122k-$213k/yrHybridFull Time
Johnson & JohnsonNYSE: JNJ: Global healthcare providing pharmaceuticals and medical technologies.
12+ YOE12+ years in medical device development and quality engineering, Bachelor's/Master's in Engineering, expertise in design controls, risk management (ISO 14971), IEC 60601, FMEA, human factors (IEC 62366), ISO 13485, and advanced statistical/reliability methods.
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.
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
NordsonNasdaq: NDSN: Manufactures precision dispensing and fluid management equipment for industry.
Knowledge of medical device quality systems (ISO 13485, 21 CFR 820), GMP/GDP, CAPA, SPC, root-cause analysis, gage R&R, supplier quality (SCAR, MRB), process and transfer validations, and internal auditing.
ISO 13485, 21CFR Part 820, GMP, GDP, SPC, SCAR, gage R&R
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
GE AerospaceNYSE: GE: Designs and manufactures jet engines and aerospace systems.
5+ YOEEstablish and lead defense quality and safety management systems, ensure regulatory compliance, lead audits and CAPA, develop teams; requires quality/engineering/manufacturing experience and QMS 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