Samsung BiologicsKorea Exchange: 207940: Global contract development and manufacturing organization for biopharmaceuticals.
Requires a bachelor's degree in engineering or equivalent, biopharmaceutical manufacturing experience, process equipment knowledge, capital project management, and familiarity with cGMP, validation, change control, investigations, and CAPA.
MerckXETRA: MRK: A science and technology providing healthcare, life science, and electronics solutions.
4+ YOEBachelor's degree in a scientific field and 4+ years of quality assurance experience in a GxP environment; knowledge of regulated documentation, audits, CAPA, FDA and EU regulations, cGMP, GLP, and data integrity.
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
TrexNYSE: TREX: Manufactures wood-alternative composite decking and outdoor living products.
5+ YOEAssociate in Engineering +10 yrs or Bachelor +5 yrs experience; Six Sigma Green Belt; knowledge of PPAP, FMEA, ISO, SPC, CAPA and quality data analysis; experience driving continuous improvement in manufacturing.
SPC, Vision Systems, PPAP, FMEA, ISO, CAPA, Quality Management System
Sunnyvale or Washington, D.C. or San Diego or Fort Walton Beach or Ann Arbor or London or Stuttgart or Munich or Stockholm or Bengaluru or Seoul or Tokyo
$150k-$200k/yrOnsiteFull Time
Applied Intuition: Developing software and simulation infrastructure for autonomous vehicles.
7+ YOE7+ years in operational compliance, transportation safety, program management, or related work, including 3+ years in a safety-critical or regulated environment; experience owning compliance frameworks, RCA, CAPA, and audit-ready records.
ISO 26262, SOTIF, UL 4600, DOT, FMCSA, OSHA, MSHA, CAPA, RCA
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
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
BIOQUALOTC Markets: BIOQ: Provides preclinical research and animal model services.
0+ YOEBachelor’s degree preferred; 0–2 years of strategic planning or project management experience; QA, regulatory audit, CAPA, data analysis, Microsoft Office, communication, and presentation skills.
Microsoft Word, Microsoft Excel, Pivot tables, Microsoft PowerPoint
Kite PharmaNASDAQ: GILD: Developing engineered cell therapies to treat and cure cancer.
3+ YOEGMP QA experience in drug substance/product manufacturing; degree in technical discipline or equivalent experience; knowledge of GMP, SOPs, investigations, deviations, CAPA; strong communication and leadership skills.
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
Meso Scale Diagnostics: Manufacturer of high-sensitivity multiplexed immunoassay systems and reagents.
4+ YOEBachelor's degree in life sciences or engineering, or relevant complaint-handling and CAPA experience; 4+ years in biotechnology, medical devices, diagnostics, pharmaceuticals, or related industry; quality and analytical problem-solving knowledge.
Microsoft Office Suite, Salesforce, Microsoft SharePoint, QMS
Universal Health ServicesNYSE: UHS: Operates acute care hospitals and behavioral health facilities.
1+ YOEActive DC RN license (or eligible), BLS and ACLS (AHA), minimum 1 year PACU/ICU/ED experience, CPAN/CAPA and BSN preferred, experience with EMR, strong communication and critical thinking.
Manager Site Operations, Facilities Maintenance, Second shift
Gaithersburg, Maryland, United States
$90k-$135k/yrOnsiteFull Time
AstraZenecaLondon Stock Exchange: AZN: Global biopharmaceutical developing and manufacturing prescription medicines.
5+ YOEBachelor's in engineering or equivalent experience, 5+ years in maintenance/engineering/facilities management, experience with AutoCAD, CMMS (SAP), BMS, cGMP compliance, capital projects, vendor management, RCA/CAPA, and people leadership.
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
California or New Hampshire or North Carolina or Denmark or Wisconsin or Taiwan or Oklahoma or Israel or British Columbia or Ontario or Minneapolis or Berlin or India or Michigan or Maryland or Florida or Vermont or Virginia or Texas or Oregon or New Mexico or Missouri or Maine or Iowa or Idaho or South Carolina or Mobile or Arkansas or Oslo or Finland or Massachusetts or Japan or France or Alabama or Kentucky or Indiana or Alaska or Nebraska or Utah or South Dakota or Montana or Nevada or Connecticut or New Jersey or Kansas or Louisiana or Ohio or Washington or Washington or Illinois or Wyoming or Hawaii or Georgia or Arizona or Ireland or Tennessee or Sweden or Spain or Rhode Island or Toronto or Heslington or Pennsylvania or Costa Rica or New York or North Dakota
$108k-$149k/yrFieldFull Time
Applied MaterialsNASDAQ: AMAT: Manufacturers of equipment for semiconductor and display production.
Engineering experience in product installation, driving install strategy, data-driven productivity improvements, CAPA participation, digital tools/AI adoption, and solving technical issues; role requires occasional travel (~25%).