MiniMed GroupNasdaq: MMED: A focused on developing insulin delivery systems and connected diabetes care to improve daily life for people with diabetes.
5+ YOEBachelor's degree with 7+ years (or advanced degree with 5+ years) in medical device/pharma quality, 3+ years CAPA experience, audit support, regulatory knowledge, and CAPA system experience.
Space Kinetic: Developing propellant-free systems for deploying payloads in space.
3+ YOEBachelor's in Engineering, 3+ years in aerospace or regulated manufacturing, working knowledge of AS9100D/AS9102, inspection methods, GD&T, CAPA, and root cause analysis.
AS9100D, AS9102, GD&T, CAPA, NIST SP 800-171, CMMC, ITAR, ERP, QMS, electronic document control systems
Quantic Electronics: Manufacturer of mission-critical electronic components and systems.
5+ YOEBachelor's in engineering/quality or related; 5+ years in quality leadership in manufacturing; experience with ISO 9001, audits, 8D/CAPA/FMEA/SPC; quality certifications preferred.
ISO 9001, 8D, CAPA, FMEA, SPC, IPC Standards, Microsoft Office
Grand Prairie or Dallas or Charlotte or Pittsburgh or Seattle or Atlanta or Sylmar
HybridFull Time
PPGNYSE: PPG: Manufacturer of paints, coatings, and specialty materials.
8+ YOE5+ MgmtBachelor's in engineering,8+ years quality experience in aerospace/regulated manufacturing,5+ years supplier quality leadership,knowledge of AS9100/AS9145/APQP/PPAP/AS9102/CAPA/8D/FMEA/MSA/SPC,Lead Auditor preferred.
SaniSure: Designs and manufactures single-use bioprocessing and fluid management systems.
5+ YOEBachelor's in engineering, 5+ years manufacturing engineering in regulated (medical device/pharma) environments; Lean Six Sigma, process validation (IQ/OQ/PQ), pFMEA, SPC/Cpk, CAPA/NCR, DOE, CAD proficiency; ability to travel up to 10%.
Lean Six Sigma, SPC, Cpk, Gage R&R, IQ/OQ/PQ, pFMEA, CAPA, NCR, CAD, Design of Experiments (DOE)
AmgenNASDAQ: AMGN: Develops and manufactures biotechnology medicines for serious diseases.
Advanced process knowledge, root-cause analysis and CAPA development experience in cGMP manufacturing; strong communication and technical judgment; flexible to support varied shifts.
Microsoft Office, EBR, MES, DeltaV, electronic quality management systems
Ensign-Bickford Aerospace & Defense: Precision energetic systems and hardware for aerospace and defense
Support customer and supplier quality in a manufacturing environment; perform quality engineering, RCCA/CAPA, audits, SPC, GD&T interpretation, and interface with suppliers/customers.
Microsoft Excel, Microsoft Word, Microsoft PowerPoint, Microsoft Project, ERP, MRP, Statistical Process Control (SPC)
Boston ScientificNYSE: BSX: Developer and manufacturer of innovative medical devices and therapies.
10+ YOE10+ MgmtBachelor’s degree and 10+ years in medical device quality systems; 10+ years leading a team; experience with FDA inspections, post-market surveillance, CAPA, and regulatory compliance.
Quantum-Systems: Develops and manufactures autonomous AI-powered unmanned aerial systems.
Perform inspections, tests, and audits; document nonconformances; support root cause analysis and CAPA; read technical drawings; use Microsoft Office; must be U.S. citizen or permanent resident.
Microsoft Word, Microsoft Excel, Microsoft Outlook, AS9100, Lean, Six Sigma
Boston ScientificNYSE: BSX: Manufacturer of interventional medical devices and technologies.
5+ YOEBachelor's in scientific/technical field, 5+ years medical device experience, proficiency with Microsoft Office, working knowledge of FDA/ISO regulations; CAPA and complaint handling experience preferred.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Design Failure Mode and Effects Analysis (DFMEA)
ResMedNew York Stock Exchange: RMD: Developing cloud-connected medical devices for sleep and respiratory care.
5+ YOEBachelor's in engineering or science,5+ years in manufacturing quality,experience with QMS/CAPA/validation/nonconformance management,leadership of QC teams,knowledge of FDA QSR,GMP,ISO 13485 and MDSAP.
Northrop GrummanNYSE: NOC: Develops and manufactures advanced aerospace, defense, and space systems.
5+ YOE4+ MgmtExperience leading quality engineering teams in manufacturing; knowledge of ISO 9001/AS9100, CAPA/RCCA, PMRB/MRB processes; DoD/Secret clearance; on-site in CA Northridge/Ridgecrest; relocation not offered.
Kindeva Drug Delivery: Develops and manufactures complex drug-device combination delivery systems.
10+ YOEBachelors in science, 10+ years analytical testing experience in pharmaceutical GxP environment, advanced GMP/GLP knowledge, experience with FTIR/HPLC/GC and other lab techniques, leading investigations and CAPA.
FTIR, HPLC, UV Spectrophotometer, Dissolution, Instron, Texture Analyzer, Gas Chromatography
Teladoc HealthNYSE: TDOC: Provides on-demand virtual medical care and mental health services.
7+ YOEBachelor's degree in engineering, quality, regulatory affairs or life sciences; 7+ years in medical device or regulated industry; ISO 13485, CAPA, audits, supplier quality, risk management, and design control experience.
ImmunityBioNASDAQ: IBRX: Develops next-generation immunotherapies for cancer and infectious diseases.
1+ YOEBachelor's in science, 1+ years validation or GMP experience, facility commissioning and equipment/facility validation, knowledge of IQ/OQ/PQ, change control, CAPA, GMPs, OSHA, and 21 CFR Part 11.
Director, Quality Management Systems (Athlone, L, IE)
Athlone or Morrisville or Pleasanton or Santa Barbara
OnsiteFull Time
TeleflexNYSE: TFX: Manufactures medical devices for critical care and surgical procedures.
Lead and maintain global QMS (ISO 13485, EU-MDR, MDSAP), manage eQMS integrations, support regulatory audits/inspections, lead CAPA and quality projects, manage teams, budgets and cross-functional stakeholders.
Ensign-Bickford Industries: Develops aerospace systems, diagnostic tests, and pet food enhancers.
Experience in manufacturing quality engineering, ISO 9001/AS9100, GD&T, SPC, supplier quality, CAPA/RCCA, Lean/continuous improvement, strong analytical and problem-solving skills, willing to travel up to 10%.
Microsoft Excel, Microsoft Word, Microsoft PowerPoint, Microsoft Project, ERP, MRP
John Paul Mitchell Systems: Sells professional-grade hair care products and styling equipment globally.
8+ YOE5+ MgmtBachelor's in relevant science,8+ years in quality/product validation in cosmetics or consumer products,5+ years people leadership,knowledge of GLP and ISO 22716,experience commissioning CRO studies,CAPA/FMEA and statistics skills.