GetingeNasdaq Stockholm: GETI B: Manufactures medical equipment for acute care and life sciences.
5+ YOEBachelor's in engineering or science required, 5+ years managing CAPA processes, proficiency with TrackWise, Minitab and Microsoft Office, knowledge of ISO 13485 and FDA 21 CFR Part 820, strong root-cause analysis and auditing skills.
TrackWise, Minitab, Microsoft Word, Microsoft Excel, Microsoft PowerPoint
Englert: Manufacturer of metal roofing and seamless gutter systems.
5+ YOEDevelop and lead quality strategy, manage quality team, maintain QMS, oversee inspections, analyze defects and drive CAPA, and lead continuous improvement in manufacturing.
QMS, ISO 9001, SPC, Lean, Six Sigma, FMEA, CAPA, CMM
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
MaerskNasdaq Copenhagen: MAERSK B: Operates container ships and provides global logistics services.
Experience implementing and maintaining QMS and ISO 9001, audit and CAPA management, process improvement, training, SOP creation, and SharePoint/workflow development.
Bristol Myers SquibbNew York Stock Exchange: BMY: Develops and distributes innovative medicines for serious diseases.
Oversee clinical study operations, manage CROs/vendors, ensure compliance with regulations and SOPs, monitor trial progress and risks, support audits and CAPAs.
MaerskNasdaq Copenhagen: MAERSK B: Provides global integrated container logistics and supply chain services.
Maintain and improve QMS and ISO compliance, lead audits, manage CAPA, train sites, implement continuous improvement and support quality KPI objectives.
NovartisNew York Stock Exchange: NVS: Develops and manufactures innovative prescription medicines for patients.
Lead global QA for CGT modalities ensuring GxP compliance, audit and inspection readiness, risk management, deviation and CAPA oversight, people management, and regulatory guidance.
BDNYSE: BDX: Manufactures medical devices, surgical instruments, and pharmacy automation systems.
8+ YOEBS in engineering or science,8+ years medical device/biologic/pharmaceutical/diagnostic experience,knowledge of 21CFR820,ISO13485,MDR/MDD,MDSAP,audit and CAPA expertise.
Kashiv BioSciences: Develops biosimilars and drug delivery systems for medicine improvement.
0+ YOEBachelor's in science/engineering, 0+ to 5+ years microbiology experience in cGMP biologics/biosimilars manufacturing (level-dependent). Knowledge of cGMP, deviation/CAPA, validation desired.
Avet Pharmaceuticals: Manufactures and distributes generic and specialty pharmaceutical products.
10+ YOEBachelor's in a scientific discipline; 10+ years QA leadership in cGMP-regulated pharmaceutical manufacturing (OSD) with inspection, validation, CAPA, and supplier oversight; proficiency with eQMS and Microsoft Office.
Electronic Quality Management Systems (eQMS), Microsoft Office Suite
Integra LifeSciencesNASDAQ: IART: Manufacturing surgical instruments and regenerative medical technology devices.
3+ YOEBachelor’s degree in science or engineering; 3-5+ years QA experience in medical device/pharmaceutical manufacturing; strong investigations, root-cause analysis, CAPA, and regulatory knowledge.
Amneal PharmaceuticalsNASDAQ: AMRX: Develops and manufactures generic and specialty pharmaceutical products.
1+ YOE1+ MgmtSupervisory QA role requiring pharmaceutical/manufacturing experience (1+ years with BA/BS or more for other credentials) and knowledge of cGMP; responsible for CAPA, audits, SOPs, and batch record oversight.
WuXi BiologicsHong Kong Stock Exchange: 2269: Provides discovery, development, and manufacturing services for biologic drugs.
1+ YOEPerform GMP sampling and QC testing of environmental, water, gas, and raw material samples; document results, investigate OOS/OOL, support CAPA and validation; proficiency with lab software and English.
Eugia: Developer and manufacturer of generic sterile injectable pharmaceuticals.
3+ YOE3+ years GMP experience, strong attention to detail, documentation and SOP authorship, review of deviations/CAPA, proficiency with Microsoft Office and SharePoint/Visio/Oracle, audit support and metrics tracking.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Outlook, SharePoint, Visio, Oracle
Cartridge Actuated Devices: Manufacturer of high-precision explosive devices and pyrotechnic components.
5+ YOEBachelor's in engineering (or equivalent) and 5+ years post-degree quality engineering experience; familiarity with ISO9000; ability to administer QMS, audits, CAPA, supplier quality; must pass ATF background check.
CareTria: Integrated platform for pharmaceutical therapy initiation and patient support.
4+ YOE4+ MgmtBachelor's in engineering/life sciences or 10+ years related experience; 4+ years GxP leadership; expertise in cGMP/GDP, internal and client/regulatory audits, CAPA, and cross-functional process improvement.
ShionogiTokyo Stock Exchange: 4507: Research-driven pharmaceutical developing innovative treatments for medical needs.
4+ YOEMinimum 4 years QA experience in sterile drug product manufacturing/oversight; CMOs; batch review; CAPA; regulatory knowledge; QA with external partners; 50% on-site in Florham Park, NJ.
ReckittLondon Stock Exchange: RKT: Produces and sells health, hygiene, and nutrition consumer products.
1+ YOEBS in engineering (manufacturing/industrial/mechanical) required; 1+ years QA or equivalent manufacturing experience; knowledge of CAPA, ISO, SPC, PFMEA, DMAIC, GMP; strong communication and data analysis skills.
Microsoft Excel, Microsoft Word, Microsoft PowerPoint, Minitab, QMS, SPC, Trackwise, InfinityQS/SPC, LEEDS, Master Control