FluenceNasdaq: FLNC: Provides energy storage systems and optimization software for renewables.
15+ YOE15+ years quality leadership in manufacturing/energy; bachelor's in engineering or related; expertise in QMS, ISO, CAPA, reliability engineering; Lean/Six Sigma experience; executive leadership and global operations experience.
Quality Management System (QMS), ISO, CAPA, Lean, Six Sigma
VB Spine: A medical device focused on supporting surgeons and ensuring design and product quality throughout the product lifecycle.
4+ YOEBachelors in science/engineering required, 4+ years in medical device or regulated industries, experience with design controls, risk management, V&V, CAPA, and quality tools; MS/CQE/CRE and Six Sigma preferred.
FMEA, GD&T, Root Cause Analysis, Minitab, Microsoft Office, CAD, CAPA, Mistake Proofing
AxaltaNYSE: AXTA: Global manufacturer of performance liquid and powder coating systems.
5+ YOE5+ years quality engineering experience in manufacturing/automotive preferred; knowledge of CAPA, FMEA, root-cause tools; Six Sigma Black Belt or ASQ CQE preferred; bachelor’s in QA/Engineering/Chemistry or equivalent experience.
CAPA, 8D, 5 Why, Failure modes Effects Analysis (FMEA), Fault Tree Analysis (FTA), ISO 9001
Samsung BiologicsKorea Exchange: 207940: Global contract development and manufacturing organization for biopharmaceuticals.
Bachelor's in a scientific discipline, experience in cGMP-regulated environments, strong auditing and CAPA management skills, familiarity with FDA/global regulatory expectations.
Granules IndiaNational Stock Exchange of India: GRANULES: Manufactures and distributes generic pharmaceutical products and active ingredients.
6+ YOEcGMP and FDA knowledge, 6+ years QA experience in pharmaceutical manufacturing (or master's with 4+ years), strong documentation, audit, CAPA, and training skills.
GAP Solutions: Providing professional services and mission support to federal agencies.
20+ YOEPh.D. in biological/social/biomedical sciences, 20+ years experience, skilled in IRB processes and 45 CFR 46, auditing, CAPA, policy and manuscript writing, and delivering regulatory training.
Northridge or California or Seattle or Washington or Boston or New York City or Los Angeles County or United States
$121k-$205k/yrOnsiteFull Time
MiniMed GroupNasdaq: MMED: A medical device developing insulin delivery systems and connected care solutions for people living with diabetes.
5+ YOEBaccalaureate degree with 7+ years (or advanced degree with 5+ years) in quality systems; experience with QMS, Change Management, CAPA, audits, and Microsoft Office; strong communication and prioritization skills.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Agile, Trackwise, Microsoft Teams, Microsoft Project, Power BI
Northrop GrummanNYSE: NOC: Develops and manufactures advanced aerospace, defense, and space systems.
8+ YOEAdvanced quality engineering experience with root-cause/CAPA, knowledge of ISO9001/AS9100, Six Sigma, ability to obtain U.S. Secret clearance, and 8+ years relevant experience (varies by degree).
PLM, SysML, Model-Based Systems Engineering (MBSE), digital twin
Northeast Foods: A food manufacturer focused on producing bakery products while maintaining high standards of food safety and quality.
Experience in food or beverage manufacturing with strong knowledge of HACCP, GMP/CGMP, ISO 9001, FDA regulations, quality audits, CAPA, Six Sigma and Lean; training and project management experience.
HACCP, GMP, CGMP, ISO 9001, FDA, Six Sigma, Lean, GD&T, GxP
McCormickNYSE: MKC: Produces and sells spices, seasonings, condiments, and flavors.
2+ YOEBSc in a technical field, 2 years management in production/processing quality, knowledge of cGMPs, SAP, MS Office, leadership and problem-solving (PDCA/RCA/CAPA), food safety program knowledge.
Theradaptive: Develops targeted regenerative medicine therapeutics for tissue repair.
4+ YOEBachelor's degree in engineering or life sciences, 4+ years MSAT/bioprocess/GMP experience, deviation/CAPA and validation experience, DOE and CPV knowledge, cleanroom aptitude, strong analytical and communication skills.
Track Wise, MasterControl, Design of Experiments (DOE), SPC
Blue Energy: Building modular nuclear power plants using shipyard manufacturing techniques.
12+ YOE3+ MgmtBachelor's in engineering,12+ years engineering experience with 5+ years in technical authority roles,knowledge of US codes/standards,nuclear QA,RCA/CAPA,MOC,and team leadership;PE or equivalent preferred.
ASME BPVC Section III, ASME NQA-1, ASME B31, IEEE, ANSI, 10 CFR 50 Appendix B, Bentley ProjectWise, Autodesk Construction Cloud, Microsoft SharePoint, Power BI, AVEVA E3D, SmartPlant, Revit, Navisworks
Venture Global LNGNYSE: VG: Develops and operates liquefied natural gas export facilities.
5+ YOEBachelor's in engineering/quality/operations required; 5+ years CI/quality/operations experience in LNG/oil & gas/manufacturing; Lean and RCA proficiency; CAPA and RCA leadership; strong facilitation and analytical skills.
Lean, Root Cause Analysis (RCA), 5-Why, Fishbone, A3
Kite PharmaNASDAQ: GILD: Developing engineered cell therapies to treat and cure cancer.
5+ YOE5+ years relevant GMP experience (5+ with MS or 7+ with BS/BA). Proficient with GMP/GLP, QA principles, Microsoft Office; experience managing deviations, CAPAs, change controls, batch review, and audits.
GMPs, GLPs, Microsoft Office, Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC), Hazard Analysis and Critical Control Points (HACCP), Failure Mode Effects Analysis (FMEA)
Quality Assurance / Configuration Management Lead - Topsecret
Centreville, Virginia, United States
$104k-$181k/yrOnsiteFull Time
ParsonsNYSE: PSN: Provides engineering and technology services for infrastructure and defense.
8+ YOEBachelor's in engineering or related field, 8+ years in QA/Configuration Management, document control, change management, CAPA, root cause analysis, requirements tracking, agile/PLM familiarity, active Top Secret clearance required.