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.
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.
Rivermaid Trading Company: Grows, packs, and ships fresh cherries and pears.
HACCP and PCQI required; experience implementing and managing SQF programs in food production; supervisory experience preferred; able to perform audits, CAPAs, traceability and training.
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
Ingersoll RandNYSE: IR: Designs and manufactures mission-critical industrial flow and compression equipment.
Bachelor's degree in engineering or related field; experience with hardware development, manufacturing, project coordination, failure investigations, RCA, CAPA, engineering documents, and Microsoft Office preferred.
Microsoft Office, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Project
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
FluidraBolsa de Madrid: FDR: Manufacturer of equipment and solutions for residential and commercial pools.
5+ YOE3+ Mgmt5+ years QC/lab experience, bachelor’s in chemistry/biochemistry/chemical engineering/biology or equivalent, 3+ years supervisory experience preferred, experience with laboratory instrumentation, CAPA, audits, and quality systems.
Microsoft Office, quality management software systems
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
PCI Pharma Services: Integrated pharmaceutical development, manufacturing, and global packaging services.
3+ YOEBachelor's degree or 3-5 years related experience; experience leading projects and teams; strong Microsoft Office skills; working knowledge of GMPs; experience with investigations, CAPA, and customer-facing quality activities.
Microsoft Word, Microsoft Excel, PowerPoint, Outlook, Microsoft Project
Hikma PharmaceuticalsLondon Stock Exchange: HIK: Develops and manufactures generic, branded, and injectable medicines.
5+ YOE5+ years related experience (or 4+ with advanced degree); BS in engineering or pharmaceutical sciences preferred; strong cGMP and validation experience; protocol writing, CAPA/change control, and technical writing skills required.
Sharp: Contract packaging and clinical services for the pharmaceutical industry.
1+ YOELead and conduct GMP investigations, perform root cause analysis, author investigation reports, recommend and implement CAPA; requires pharmaceutical packaging experience, strong writing and critical thinking, and ability to support audits.
WuXi AppTecShanghai Stock Exchange: 603259: Provides global R&D and manufacturing services for life sciences
2+ YOEBachelor’s degree in a scientific or technical discipline, 2–3 years of pharmaceutical or biopharmaceutical quality experience, GMP manufacturing, document control, LMS, QA oversight, deviations, root-cause analysis, and CAPA experience.
Veeva Vault, Learning Management System (LMS), Microsoft SAP