MIT Lincoln Laboratory: Building advanced technology prototypes for national security.
5+ YOEMaster's degree in engineering or Bachelor's +5 years, leadership in quality management, SPC and root-cause analysis experience, corrective action and supplier quality expertise, ability to obtain Secret clearance.
Johnson & JohnsonNYSE: JNJ: Develops and manufactures pharmaceutical drugs and medical devices.
1+ YOETechnical degree or equivalent experience,1–5 years in manufacturing/engineering/quality,knowledge of NC/CAPA and quality processes,ability to manage documentation,testing,logistics,and continuous improvement.
Quest DiagnosticsNYSE: DGX: Provides clinical laboratory diagnostic testing and health information services.
5+ YOE5+ years quality engineering experience in regulated medical device/IVD manufacturing; strong knowledge of FDA QMSR, ISO 13485/14971, GMPs, process validation, change control, CAPA, supplier quality, eQMS; Bachelors required.
eQMS, quality analytics tools, electronic quality systems
Emerald Technologies: Provides design and manufacturing services for complex electronic assemblies.
4+ YOEMinimum 4 years engineering/quality experience in PCBA or PCB manufacturing; familiarity with IPC-A-610 and IPC J-STD-001; experience with SMT, AOI/X-ray, root cause analysis, process optimization, and production support.
Arden Hills or Valencia or Spencer or Marlborough or Quincy or Maple Grove or Coventry
$102k-$194k/yrHybridFull Time
Boston ScientificNYSE: BSX: Manufacturer of interventional medical devices and technologies.
7+ YOEBachelor's in engineering/science, 7+ years in quality/engineering/operations/QA, 3+ years in medical device or regulated industry, business process design and quality systems knowledge; SAP S/4HANA experience preferred.
AmazonNASDAQ: AMZN: Global online retail and cloud computing technology provider.
7+ YOEBachelor's in engineering or STEM, 7+ years quality engineering experience in electromechanical/precision hardware, experience with APQP/PPAP, DFMEA/PFMEA, metrology (CMM), MRB, SPC/MSA, and supplier quality processes; Six Sigma/CQE preferred.
Integra LifeSciencesNASDAQ: IART: Manufacturing surgical instruments and regenerative medical technology devices.
5+ YOEBachelor's degree with 10+ years, master's with 8+ years, or doctorate with 5+ years in engineering or quality; medical device or pharmaceutical experience, process validation, IQ/OQ/PQ, data analytics, and regulatory knowledge required.
IQ/OQ/PQ, FDA, ISO 13485, ISO 9001, CMDR, MDR, 21 CFR Part 11, cGMP
Johnson ControlsNYSE: JCI: Provides integrated building technologies including HVAC, fire, and security systems.
2+ YOE2+ years manufacturing quality experience; ability with part prints, inspection tools (micrometers, calipers, CMM, vision), create inspection plans, root cause analysis, ISO 9001 processes; comfortable with spreadsheets and Word; BS in technical field preferred.
micrometer, caliper, CMM, vision systems, Microsoft Excel, Microsoft Word
Johnson & JohnsonNYSE: JNJ: Provides pharmaceutical products and medical technology healthcare solutions.
1+ YOETechnical degree or equivalent experience,1+ years in manufacturing/engineering/quality,knowledge of quality systems (NC,CAPA),strong organization,communication,and problem-solving skills.
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
Mack Technologies: Provides contract electronics manufacturing and system assembly services.
3+ YOEBSc in engineering required, 3+ years manufacturing engineering experience, PCBA/SMT/wave soldering knowledge, PFMEA/PCA/DFM experience, lean and TQM experience, ISO quality systems, strong communication and problem-solving skills.
PCBA, SMT, wave soldering, Lean, PFMEA, 5 why, 8D, ISO
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.
JabilNYSE: JBL: Provides manufacturing and supply chain solutions for global brands.
8+ YOEBachelor's in engineering or equivalent,8+ years quality/new product/process or manufacturing engineering in medical device industry,ISO 13485 and CAPA experience,validation and audit experience,Excel power-user and BI basics.
Microsoft Excel, Microsoft Word, Microsoft PowerPoint, Excel/Sheets, Power BI, Tableau, Looker
Senior Quality Engineer - Medical Device Engineer #5452
Taunton, Massachusetts, United States
OnsiteFull Time
ECI: Provides regulatory and engineering consulting for life sciences companies.
8+ YOEBachelor's in engineering, ~8 years quality/design quality experience in medical device industry, familiarity with FDA/ISO standards, SPC/DOE/GR&R/FMEA/CAPA, tooling and manufacturing processes, and Microsoft Office proficiency.
5+ YOEBachelor's in engineering or equivalent; 5+ years manufacturing quality experience in medical device industry; experience with Class II/III devices, FDA/ISO 13485 QMS, process validation, IQ/OQ/PQ, SPC, DOE, and root-cause analysis.
Westborough or Worcester or Center Valley or United States
$98k-$135k/yrHybridFull Time
OlympusTokyo Stock Exchange: 7733: Manufactures medical endoscopes and minimally invasive surgical tools.
5+ YOEBA/BS in life science, engineering, or physical science; 5+ years supplier quality engineering; experience with APQP/FAI/SCAR/SCN, ISO 9001/13485 and FDA processes; fiber-optic laser system or medical device experience preferred; ~20% travel.
Boston ScientificNYSE: BSX: Developing and manufacturing innovative medical devices for less-invasive treatments.
2+ YOEBachelor's degree in engineering, technology, life science, or related field; 2+ years in medical device or regulated manufacturing; Lean, Six Sigma, process improvement, and root cause analysis experience.
RTXNYSE: RTX: RTX provides advanced aerospace and defense systems and services.
8+ YOEBachelor's in STEM + 8 years related experience, U.S. citizenship with ability to obtain/maintain DoD Secret clearance (active required day 1), experience with root cause analysis, quality metrics, manufacturing processes, and interpreting drawings.
Advanced Product Quality Planning (APQP), PFMEA, SPC, pareto analysis, cause/effect diagrams, process mapping, J-STD-001, ISO 9001, AS9100
Senior Quality Engineer - Thick Film & Microelectronics Assembly
Canton, Massachusetts, United States
$110k-$160k/yrOnsiteFull Time
Remtec: Manufacturing advanced ceramic packaging and metalized substrates for electronics.
3+ YOEBachelor's in engineering or materials science, 3+ years quality engineering in microelectronics/semiconductor manufacturing, experience with thick film processes, AS9100/ISO9001 familiarity, root cause analysis, SPC/DoE, and APQP/PPAP/DFMEA/PFMEA.
AS9100, ISO 9001, SPC, DoE, APQP, PPAP, DFMEA, PFMEA, MIL Standard