One Stop SystemsNASDAQ: OSS: Designs high-performance rugged computing and storage for edge applications.
3+ YOE3+ years quality/inspection experience in manufacturing, AS9100/ISO9001 knowledge, ability to perform inspections, root-cause analysis, corrective actions, supplier quality, and use Excel/ERP systems.
Microsoft Excel, Microsoft Office, ERP/MRP, quality-management software
AbbottNYSE: ABT: Provides medical devices, diagnostics, and science-based nutritional products.
2+ YOE0-2 years of related experience; bachelor’s in science/engineering; basic quality systems knowledge; able to work in a quality environment; familiarity with FMEAs and design controls; potential manufacturing experience preferred.
Primally Pure: Manufacturer and retailer of natural, non-toxic skincare products.
3+ YOE3+ years in quality control within production/manufacturing; bachelor in science or business; GMP knowledge; strong communication; data analysis.
Quality management systems, CAPA, Statistical analysis, Data analysis, GMP
Bothell or Cambridge or San Diego or Plymouth or Reedsville
$134k-$186k/yrHybridFull Time
PhilipsEuronext Amsterdam: PHIA: Manufactures medical imaging systems and personal care appliances.
5+ YOEBachelor's/Master's in engineering or science, 5+ years relevant experience with demonstrated leadership, mastery of quality systems/CAPA/FMEA, familiarity with medical device regulations (EU-MDR, 21CFR820), and ability to perform post-market risk assessment.
EU-MDR, 21CFR820, ISO 13485, ISO 14971/TS 24971, IEC 60601, IEC 62366, IEC 62304, IEC 60812/VDA FMEA Handbook, FMEA
AbbottNYSE: ABT: Manufactures medical devices, diagnostics, and nutritional health products.
2+ YOEBachelor's in engineering or technical field (or equivalent), minimum 2 years technical experience, knowledge of FDA/GMP/ISO 13485, project leadership, quality tools, and strong communication skills.
Zenix Aerospace: Manufactures structural airframe and engine components for aerospace OEMs.
3+ YOEBachelor's or equivalent, 3+ years quality/manufacturing experience, experience with ISO/AS9100/Six Sigma and statistical process controls, proficiency with spreadsheets and Microsoft Word/Excel, strong attention to detail and teamwork.
PPAP, APQP, PFMEA, MSA, FAIR, FPA, AS9100, ISO, Six Sigma, Microsoft Excel, Microsoft Word
Solecta: Manufactures advanced polymeric membranes for industrial liquid separation processes.
2+ YOEBachelor's in engineering required, 2+ years in regulated manufacturing, proficiency with GD&T, CAD and ERP, experience with Lean/Six Sigma, inspections, root-cause analysis, PPAP/FMEA, and quality documentation.
Geometric Dimensioning and Tolerancing (GD&T), CAD, ERP, Microsoft Excel, Microsoft Word, Email, Flat Cell Tester, Visual Inspection Machine, calipers, micrometer, rules, gauges
ResMedNew York Stock Exchange: RMD: Developing cloud-connected medical devices for sleep and respiratory care.
Bachelor in engineering/science, experience with quality systems in medical or regulated industry, moderate audit experience, ability to manage CAPA and audit programs, knowledge of ISO13485 and FDA 21 CFR Part 820 preferred.
5+ YOEEnsure compliance with QSR/ISO/21CFR820, lead internal and 3rd-party audits, review and approve complex quality documentation, BA/BS in biological or chemical science, 5+ years quality experience.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint
nVentNYSE: NVT: Manufactures electrical connection and protection products for industrial systems.
5+ YOEBachelor's in Engineering, ~5+ years manufacturing/quality engineering experience (aerospace/defense preferred). Proficiency with MS Office/Excel, Minitab, QMS (Intelex), Lean/Six Sigma, supplier quality, auditing, and AS9100.
Microsoft Office, Microsoft Excel, Minitab, Intelex
Winchester Interconnect: Designs and manufactures custom connectors and cable assemblies.
3+ YOEBS degree and 3+ years quality experience required; proficiency with Six Sigma, lean, DFx, MSA, DOE, FMEA, process auditing, root cause analysis, ERP/databases and tight-tolerance measurement; NPI/APQP and regulatory compliance experience.
DexcomNASDAQ: DXCM: Develops continuous glucose monitoring systems for diabetes management.
13+ YOEExtensive medical device quality experience with FDA 21 CFR 820 and ISO 13485, audit readiness, leading investigations, data analysis (Excel,JMP), and cross-functional quality solutions; typically 13+ years experience.
BDNYSE: BDX: Manufactures medical devices, surgical instruments, and pharmacy automation systems.
5+ YOEBachelor's in engineering or science, 5+ years quality experience in medical device industry, knowledge of FDA/QMS/ISO 13485/IVDR, audit support, document/change management, project and technical writing skills.
U.S. Navy: Conducts maritime defense and provides aircraft maintenance services.
1+ YOEAt least one year specialized QA experience equivalent to GS-09: applying quality/industrial engineering methods, conducting technical analyses, root-cause investigations, CAPA, and quality management reviews.
Ascential Technologies: Designs and manufactures automated testing and assembly equipment.
5+ YOEBS in engineering/applied science plus 5+ years quality/operations experience, 2+ years in regulated industries preferred; experience with ISO 9001/13485, RCA, supplier audits, failure investigations, and quality improvement.