HologicNASDAQ: HOLX: Develops medical technology for women's healthcare and diagnostics.
Experience in quality assurance, quality systems, CAPA, root cause analysis, audits, data analysis, KPIs, procedures, training materials, and regulated industries; strong communication and independent judgment required.
Quality Management Systems (QMS), Corrective and Preventive Action (CAPA), Quality Plans (QPLs), Key Performance Indicators (KPIs)
Waters CorporationNYSE: WAT: Provider of analytical laboratory instruments and software solutions.
10+ YOEBachelor's in engineering/business/mathematics/science,10+ years quality assurance experience, ISO 9001 QMS knowledge, Certified Lead Auditor (ISO 9001), CAPA and continuous improvement experience.
IntegerNYSE: ITGR: Manufactures medical devices and components for global healthcare companies.
3+ YOEBachelor's in engineering or 3+ years relevant experience; knowledge of QMS, FDA and international regulations, process validation, CAPA and Microsoft Office.
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.
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.
CSLASX: CSL: Develops and manufactures biopharmaceutical products and vaccines.
7+ YOEBachelor's degree or equivalent in life sciences and 7+ years of pharmacovigilance experience in multinational pharmaceuticals; requires regulatory, GxP, inspection, data, CAPA, and SOP expertise.
Teledyne TechnologiesNYSE: TDY: Manufactures sensors, cameras, and electronics for aerospace and defense.
7+ YOE3+ MgmtExperienced quality leader in defense/aerospace or space programs; AS9100/ISO9001; supplier quality, audits, MRB, CAPA; Six Sigma/Lean; high reliability manufacturing.
ERP/MRP, QMS, SAP, Deltek Costpoint, Microsoft Office, Adobe Acrobat
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.
CSLASX: CSL: Global biotechnology producing plasma-derived and recombinant therapies.
7+ YOEBachelor's degree or equivalent in life sciences and 7+ years of pharmacovigilance experience in multinational pharmaceuticals; requires GxP, regulatory inspection, CAPA, SOP, data, and PV process expertise.
Honeywell InternationalNASDAQ: HON: Designs and manufactures technologies for aerospace, buildings, and industry.
3+ YOEBachelor's in a technical discipline, 3+ years quality engineering experience in supply chain/manufacturing, proficiency with FMEA, SPC, Six Sigma, ISO 9001, root cause analysis and CAPA.
FMEA, SPC, Six Sigma, ISO 9001, ERP, Lean, Kaizen, quality management software
Associate Director, Quality Assurance (Clinical Research Preferred)
Durham or Indianapolis or Wayne
$89k-$247k/yrRemoteFull Time
IQVIANYSE: IQV: Provides clinical research and healthcare data analytics services.
10+ YOE10+ years QA experience in pharmaceutical/biotech/CRO/clinical research, strong GxP/GCP knowledge, audit and CAPA experience, leadership, risk assessment, and Microsoft Office proficiency.
Mission Critical Group: Designs, manufactures, and services critical power infrastructure solutions.
Two-year STEM degree or equivalent manufacturing experience; knowledge of quality control, technical drawings, testing equipment, statistics, root cause analysis, CAPA, and safety requirements; Microsoft proficiency.
ISO 9001, 8D, 5Why, PFMEA, Kaizen, Microsoft Excel, Microsoft Word, Microsoft PowerPoint, Microsoft Outlook
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
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.
Johnson & JohnsonNYSE: JNJ: Provides pharmaceutical products and medical technology healthcare solutions.
4+ YOEBachelor’s degree in a scientific, medical, or related discipline; 4+ years in healthcare; GCP or clinical trial experience; risk management, ICH guidelines, inspection, CAPA, data analysis, and project planning experience.
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.
Senior Supplier Quality Engineer - Exton, PA (82342)
Exton, Pennsylvania, United States
$115k-$125k/yrOnsiteFull Time
dsm-firmenichEuronext Amsterdam: DSFIR: Produces ingredients for nutrition, health, and beauty products.
8+ YOEBS in engineering or materials, 8+ years quality engineering/supplier management in regulated industry, ISO13485 lead auditor, experience with supplier qualification, 21 CFR 820, SPC, CAPA, and statistical analysis.
Microsoft Word, Microsoft Excel, Microsoft Outlook, Minitab