AbbottNYSE: ABT: Manufactures medical devices, diagnostics, and nutritional health products.
2+ YOEAssociates degree or equivalent, 2+ years in a regulated environment or investigations, CAPA/investigation and project management skills, attention to detail, strong written and oral communication; FDA QSR/ISO13485 knowledge preferred.
AbbottNYSE: ABT: Provides medical devices, diagnostics, and science-based nutritional products.
2+ YOEAssociate degree or equivalent, 2+ years in a regulated environment or investigations, project management and investigation skills, attention to detail, strong written and oral communication.
Afton Scientific: Provides aseptic manufacturing and sterile filling for injectable pharmaceuticals.
Bachelor’s degree in biology or related field; strong FDA/EU GMP knowledge; lot release, deviation management, CAPA; regulatory inspections; leadership.
Alkegen: Manufactures high-performance materials for insulation, filtration, and batteries.
3+ YOE3+ years manufacturing experience; process control, variation reduction, root cause analysis (RCA/8D/CAPA), scrap/yield improvement, process documentation, and hands-on production floor support.
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
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.
OnterrisNYSE: ONT: Global provider of environmental consulting, testing, and remediation services.
1+ YOE1+ years lab/QA experience, bachelor’s in a scientific field or equivalent, knowledge of lab procedures, GDP/CAPA/RCA familiarity, strong communication and organizational skills.
Microsoft Word, Microsoft Excel, Microsoft SharePoint, Microsoft PowerPoint, LIMS
United TherapeuticsNasdaq: UTHR: Develops rare disease therapies and manufactured transplantable organs.
6+ YOE8+ years GMP/QSR experience with Bachelor's or 6+ years with Master's; expertise in cGMP, environmental monitoring, QC microbiology, inspections, CAPA, deviations, and electronic quality systems.
PerkinElmer: Provides analytical instruments and laboratory services for scientific industries.
1+ YOEExperience with CAPA, document control, metrology/calibration, records management, and training in ISO 17025 or regulated labs; HS diploma or associate degree plus relevant lab/manufacturing experience.
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.
Associate Director, Technical Operations - Small Molecule Drug Substance
Elkton, Virginia, United States
$142k-$224k/yrOnsiteFull Time
Merck & Co.NYSE: MRK: Produces prescription medicines, vaccines, and animal health products.
10+ YOEDegree in chemistry/chemical engineering, 10+ years API process development/manufacturing, cGMP experience, process scale-up/technology transfer, deviation/CAPA investigations, and regulatory inspection readiness.
Lynchburg or Saint-Jean-sur-Richelieu or San Carlos
$67k-$84k/yrOnsiteFull Time
Delta Star: Manufactures medium power transformers and mobile substations for power grids.
3+ YOEBachelor's in a technical field,3+ years in quality systems or manufacturing,experience with ISO 9001:2015,audits,supplier quality,FMEA,CAPA,and statistical problem solving;lead auditor certification preferred.
AdvanSixNYSE: ASIX: Manufactures nylon resins, chemical intermediates, and agricultural fertilizers.
5+ YOEBachelor's in chemistry/engineering, 5+ years quality experience in chemical/process manufacturing, knowledge of lab operations, SPC, LIMS, SAP, audit/CAPA, ISO 9001/RC14001; strong leadership and communication.
HitachiTokyo Stock Exchange: 6501: Global provider of digital systems and social infrastructure solutions.
Bachelor's degree or 3+ years quality systems experience; working knowledge of ISO 9001:2015, audits, CAPA, document control, PFMEA/Control Plan support, and quality data analysis in manufacturing.
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