152 quality systems engineer jobs at 93 companies in Concord, MA
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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.
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.
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.
Aspen AerogelsNYSE: ASPN: Manufacturing high-performance aerogel insulation for energy and transportation.
5+ YOEBachelor’s degree in a relevant technical field, 5+ years of quality management system experience, IATF 16949 lead auditor qualification, automotive core tools knowledge, audit coordination, problem-solving, and willingness to travel internationally.
ISO 9001, IATF 16949, VDA 6.3, APQP, PPAP, FMEA, Control Plan, SPC, MSA, DMAIC, 8D, 5 Whys, Fishbone Diagrams, DFMEA, PFMEA, DOE, Electronic Medical Records (EMR)
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.
EPTAM Precision Solutions: Manufactures high-precision components for medical and aerospace markets.
3+ YOEThree years of progressive manufacturing or quality experience in FDA and ISO 13485 environments, with QMS and operations knowledge. A bachelor's degree in engineering or a relevant STEM field is preferred.
Quality Management System (QMS), CAPA, Six-Sigma, Poka-Yoke, Measurement System Analysis
Aspen AerogelsNYSE: ASPN: Manufacturer of high-performance aerogel insulation and thermal barrier materials.
Bachelor’s degree preferred in a relevant technical field; 5+ years of quality management experience in automotive, chemical, or manufacturing; IATF 16949 lead auditor qualification and Automotive Core Tools expertise required.
ISO 9001, IATF 16949, VDA 6.3, 8D, 5 Whys, Fishbone Diagrams, DMAIC, APQP, PPAP, FMEA, Control Plan, SPC, MSA, DFMEA, PFMEA, DOE
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.
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+ YOEBS/MS in engineering, life sciences, or related field; 3+ years in quality systems in a regulated industry (medical device preferred); working knowledge of FDA QSR (21 CFR Part 820) and ISO 13485; strong technical writing and communication; proficiency with Microsoft Excel, Word, and Visio.
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.