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)
West Pharmaceutical ServicesNYSE: WST: Manufactures packaging and delivery systems for injectable medicines.
10+ YOEBachelor's degree or equivalent experience and 10+ years in quality assurance or regulated laboratory operations, with expertise in GMP, GLP, ISO, investigations, CAPA, audits, and data integrity.
ALCOA+, CAPA, Quality Management System (QMS), Standard Operating Procedures (SOPs), Microsoft Excel
Senior Specialist, Americas Product Compliance & Site Quality
Bethlehem or Canada or South America
OnsiteFull Time
Evident: Manufactures industrial non-destructive testing and remote visual inspection equipment.
5+ YOEBachelor's degree or higher and at least five years of medical device quality assurance or regulatory affairs experience, including FDA, ISO, audits, CAPA, and cross-functional work.
FDA CDRH, ISO 9001, ISO 13485, CAPA, Standard Operating Procedures (SOPs), MDR
Irvine or Somerset or Piscataway or Titusville or Horsham or West Chester or Bridgewater or Jacksonville or Malvern or Princeton or New Brunswick or Raritan or Milpitas or Limerick
$122k-$213k/yrHybridFull Time
Johnson & JohnsonNYSE: JNJ: Develops and manufactures pharmaceutical drugs and medical devices.
8+ YOEBachelor's degree and 8+ years in a regulated industry required, with cross-functional program leadership, supply chain, risk management, CAPA, root cause analysis, and global team experience.
Qnity ElectronicsNYSE: Q: Manufactures materials and solutions for the semiconductor industry.
2+ YOEBachelor’s degree in engineering or a related technical discipline plus 2+ years in semiconductor, aerospace and defense, or related manufacturing; root cause, CAPA, SCAR, audit, and quality systems experience required.
Salesforce, Statistical Process Control (SPC), Process Control System (PCS), RCAF, 5-Why, Fishbone, 8D, CAPA, SCAR, PFMEA, FMEA, Control Plans, Control Charts, Lean Manufacturing, Six Sigma
Reynolds Advanced Materials: Distributor of mold-making, casting, and prototyping materials.
3+ YOEBachelor's degree in quality, operations, chemistry, business, or related field; 3+ years in quality assurance or analytical problem-solving; experience with quality systems, RCA, CAPA, audits, or process improvement.
International Organization for Standardization (ISO), Standard Operating Procedures (SOPs), Root Cause Analysis (RCA), Corrective and Preventive Action (CAPA), Six Sigma Green Belt, Six Sigma Black Belt
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.
FMI: Contract manufacturer of personal, health, and home care products.
8+ YOE8+ MgmtBachelor's in science/engineering/microbiology/chemistry, 8+ years progressive quality leadership in manufacturing, experience managing teams (≥8), knowledge of FDA/cGMP, audits, CAPA, SPC, ERP, and Microsoft Office.
Quality Management System (QMS), ERP systems, Microsoft Office Suite, Microsoft Excel, Microsoft Word, Microsoft Outlook, Statistical Process Control (SPC), CAPA, Lean Manufacturing, Six Sigma
Limerick or Irvine or New Jersey or Bridgewater or Raritan or Titusville or New Brunswick or Piscataway or Princeton or Somerset or Pennsylvania or West Chester or Horsham or Malvern or Jacksonville or Milpitas
€85k-€146k/yrHybridFull Time
Johnson & JohnsonNYSE: JNJ: Provides pharmaceutical products and medical technology healthcare solutions.
8+ YOEBachelor's degree and 8+ years in medical device, pharmaceutical, healthcare, or regulated industry; requires cross-functional leadership, supply chain, project management, risk mitigation, root cause analysis, and CAPA experience.
Adare Pharma Solutions: Global CDMO specializing in advanced drug delivery technologies.
5+ YOE3+ MgmtBachelor's degree in engineering, mathematics, or life sciences; 5+ years in a GMP packaging environment; 3+ years of people management; serialization, resource planning, Lean Six Sigma, technical writing, deviation management, CAPA, ERP, and Microsoft Office experience.
Microsoft Office, ERP, Lean Six Sigma, CAPA, cGMP, CFR
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.
Sharp: Provides contract packaging and clinical services for life sciences.
Leading and conducting root-cause investigations for non-conformances and complaints, authoring reports in QualityOne, designing CAPAs, collaborating with SMEs, and implementing corrective actions.
NestleSIX Swiss Exchange: NESN: Produces and sells food, beverages, and nutritional products.
2+ YOEHigh school diploma/GED and 2+ years QA experience in manufacturing or related environment; ensures compliance, manages CAPAs, and supervises QA technicians.
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.
ChristianaCare: Provides hospital care and outpatient medical services.
2+ YOEPart-time PACU RN with at least two years' experience in Critical Care/Emergency/Stepdown; BSN preferred; BLS, ACLS, PALS; CCRN/CPAN/CAPA preferred.