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
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
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.
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.
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.
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
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.
Director of Quality Assurance - Global Distribution & Logistics.
Frederick or Raleigh or Greencastle
$160k-$240k/yrOnsiteFull Time
Thermo Fisher ScientificNYSE: TMO: Sells equipment and chemicals for scientific research and healthcare.
10+ YOE5+ MgmtBachelor's degree, 10+ years in regulated medical device/pharma with 5+ years leading quality; expertise in QMS, 21 CFR Part 820, ISO 13485, MDR/IVDR, distribution/cold chain, CAPA, auditing, and continuous improvement.
GE AerospaceNYSE: GE: Designs and manufactures jet engines and aerospace systems.
3+ YOEBachelor’s degree in engineering or related field; 3+ years aerospace/MRO experience; knowledge of FAA Part 145 and AS9100D/AS9110; strong quality and product safety leadership.
AS9100, AS9110, FAA Part 145, FMEA, CAPA, Root cause analysis