109 quality systems engineer jobs at 67 companies in Woonsocket, RI
🚀PromotedHiringCafe
Founding Backend / Infra Engineer
Cupertino, CA, US
$160k-$300k/yrOn-SiteFull Time
HiringCafe: Building a 100× better job search engine to take on Indeed and LinkedIn.
Own the crawlers, pipelines, and infrastructure powering a real-time job search engine. Strong Node.js and Python fundamentals; bonus points for security and reverse-engineering chops.
Boston ScientificNYSE: BSX: Developer and manufacturer of innovative medical devices and therapies.
5+ YOEBachelor's degree in engineering/quality/life sciences, 5+ years quality systems experience in a regulated industry, knowledge of ISO 13485/21 CFR Part 820/EU MDR, digital quality systems support, audits, CAPA, 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: Manufacturer of interventional medical devices and technologies.
5+ YOEBachelor's degree required, 5+ years in quality systems in a regulated industry, knowledge of ISO 13485/21 CFR Part 820/EU MDR, experience with digital quality systems, audits, CAPA, and cross-functional collaboration.
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.
Senior Quality Systems Engineer (Marlborough, MA, US, 01752)
Marlborough or Arden Hills or Maple Grove
$89k-$170k/yrHybridFull Time
Boston ScientificNYSE: BSX: Developing and manufacturing innovative medical devices for less-invasive treatments.
5+ YOEBachelor's in engineering/quality/life sciences, 5+ years quality systems experience in a regulated industry, knowledge of ISO 13485/21 CFR 820/EU MDR, digital quality systems experience, audit/CAPA support, and process ownership.
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.
Vor BioNASDAQ: VOR: Developing targeted therapies for chronic autoimmune diseases.
3+ YOE3+ years in GxP quality systems with hands-on eDMS/eQMS/LMS experience, Bachelor's in life sciences or engineering, knowledge of FDA/EMA/ICH requirements, training and document management, and cross-functional collaboration.
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
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.
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
Draper: Designs and develops advanced guidance and navigation technologies.
7+ YOE7-10 years in quality engineering; bachelor’s in engineering; Lean Six Sigma; ISO 9001:2015 and AS9100; ability to lead cross-functional teams and resolve complex issues; security clearance required.
Lean Six Sigma, ISO 9001:2015, AS9100, Quality standards
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