71 quality systems engineer jobs at 45 companies in Eliot, ME
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Quality Systems Engineer
Danvers or Colorado or Washington
$79k-$128k/yrRemoteFull Time
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.
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.
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.
Quality Systems Engineer – CAPA and Process Improvement
Manchester, New Hampshire, United States
OnsiteFull Time
DEKA Research & Development: Designs and develops advanced medical and robotic technologies.
3+ YOERequires a BS/MS in engineering or life sciences, 3+ years in quality systems in a regulated industry, FDA 21 CFR Part 820 and ISO 13485 knowledge, and proficiency with Microsoft Office tools.
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.
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.
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.
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
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.
VicorNASDAQ: VICR: Designs and manufactures high-performance modular power conversion systems.
5+ YOE5+ years product quality engineering in semiconductor/electronics manufacturing; strong knowledge of ISO 9001:2015 and IATF16949; Six Sigma Black Belt or CQE; statistics with JMP or Minitab; experience with PLM systems; BSEE or BSME required.
JMP, Minitab, Omnify, Agile, Matrix One, Microsoft Project, Visio
Meridian Bioscience: Develops and manufactures clinical diagnostic kits and laboratory reagents.
4+ YOEBachelor of Science in engineering or science, 4+ years in OEM medical device manufacturing, and knowledge of GMP, FDA regulations, ISO 13485, quality systems, CAPA, and electronic documentation.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, electronic document management systems, 21 CFR Part 820, ISO 13485, IVDR, GMP, CAPA, FMEA
Laborie: Manufacturer of specialized medical diagnostic and therapeutic equipment.
8+ YOEBachelor's in engineering or related field,8+ years QA experience,expertise with ISO 13485 and 21CFR quality systems,auditing and statistical methods,leadership and decision-making skills.