92 quality systems engineer jobs at 58 companies in East Providence, RI
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Quality Systems Engineer III
Indianapolis or Quincy or Plainfield
$82k-$156k/yrRemoteFull Time
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.
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)
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.
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.
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.
General Dynamics Electric BoatNYSE: GD: Designs, builds, and maintains submarines for the U.S. Navy.
1+ YOEBS in Engineering required, 1+ years waterfront/quality/design engineering experience preferred; must obtain DoD security clearance; proficiency in Microsoft Office and engineering software; experience with causal analysis, quality systems, audits, and technical writing preferred.
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.
Mesa or Castroville or Hollister or Carrollton or North Kingstown or Tokyo
OnsiteFull Time
FujifilmTokyo Stock Exchange: 4901: Provider of diagnostic imaging and healthcare technology solutions.
1+ YOEBachelor's degree in a relevant engineering field, 1–3 years of QA systems experience, MS Office proficiency, effective communication, and knowledge of quality systems and statistics.
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
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
Foundation Medicine: Molecular profiling for personalized cancer treatment and research.
5+ YOE5+ years in quality systems or eQMS support, bachelor’s in related field or equivalent, experience with eQMS governance/validation, Veeva Vault preferred, strong technical writing and regulatory knowledge.
TeleflexNYSE: TFX: Manufacturer of medical devices for surgery and critical care.
6+ YOEBachelor's degree in engineering or related technical field; 6+ years in quality or related technical roles in medical devices or regulated manufacturing; expertise in quality systems, design control, validation, risk management, investigations, and CAPA.
FDA QSR (21 CFR 820), ISO 13485, EU MDR, MDSAP, DFMEA, PFMEA, 5-Why, Fishbone, DMAIC, PDCA, IQ/OQ/PQ, CAPA, Six Sigma
Senior Quality Systems Engineer- CAPA/Complaints Support - Medical Device #8161
Boston, Massachusetts, United States
OnsiteContract, Full Time
ECI: Provides regulatory and engineering consulting for life sciences companies.
5+ YOE5+ years medical device experience, Bachelor’s in biomedical/mechanical/electrical engineering required, experience executing CAPA, regulatory knowledge for Class II/III devices, strong analytical and problem-solving skills.
Draper: Designs and develops advanced guidance and navigation technologies.
7+ YOEBachelor of Science in engineering required, with 7–10 years of quality or engineering experience. Requires Lean Six Sigma, ISO 9001:2015 and AS9100 knowledge, analytical skills, and ability to lead quality teams.
HoneywellNASDAQ: HON: Manufactures aerospace products, building technologies, and industrial control systems.
2+ YOEHigh school diploma, 2+ years in manufacturing or quality, blueprint interpretation, inspection tools, measurement systems, communication, problem-solving, and basic computer skills required; quality certifications and SAP preferred.
Microsoft Office, SAP, CMM, SPC, QMS, ISO 9001, IATF 16949, Lean, Six Sigma, RCA, CAPA, FAI
Smith & NephewLondon Stock Exchange: SN: Develops medical equipment for tissue repair, regeneration, and replacement.
3+ YOEBachelor's in engineering, 3+ years quality engineering in manufacturing (regulated industry preferred). Experience with CAPA, nonconformance, PFMEA, measurement system analysis, IQ/OQ/PQ, statistical analysis, and ISO/FDA medical device standards.