140 capa jobs at 97 companies in Manhattan Beach, CA
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Manager, R&D Quality Audits, Inspections and CAPA
Foster City or Thousand Oaks or El Segundo or Santa Monica or Parsippany
$136k-$176k/yrHybridFull Time
Kite PharmaNASDAQ: GILD: Developing engineered cell therapies to treat and cure cancer.
4+ YOERequires PharmD/PhD with relevant experience, master's/MBA plus 4+ years, or bachelor's plus 6+ years in quality and compliance. Strong GCP/GVP auditing, CAPA, inspection readiness, analytical, communication, and project skills.
Applied Medical: Manufacturer of advanced medical devices and surgical products.
Bachelor's in Engineering/STEM required (or related experience). Strong problem solving, root cause analysis, statistics, and communication. Working knowledge of Microsoft Office; ETQ Reliance experience preferred.
Microsoft Office, Microsoft Word, Microsoft Excel, Microsoft Outlook, ETQ Reliance
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
Teledyne TechnologiesNYSE: TDY: Manufactures sensors, cameras, and electronics for aerospace and defense.
5+ YOEBachelor's degree in a related discipline and 5–10 years of quality management experience in regulated manufacturing; expertise in QMS, ISO standards, MDR, audits, CAPA, risk, and supplier quality.
Microsoft Office, Dynamics AX, CRM, Power BI, Lean Manufacturing, 6 Sigma, Kaizen, ISO 9001:2015, ISO 13485:2016, EU Medical Device Regulation (MDR) 2017/745, ISO 14971, CAPA
Karman Industries: Modular electric heat pumps for industrial thermal energy management.
5+ YOE5+ years in quality engineering; hands-on QMS ownership; working knowledge of ISO 9001 and audit process; experience with CAPA, RCA, and structured problem solving; ability to work autonomously.
2+ YOEHigh school diploma or equivalent, 2+ years of quality assurance experience preferred, knowledge of SQF, HACCP, GMP, FDA regulations, quality testing equipment, root cause analysis, and CAPAs.
Microsoft Word, Microsoft Excel, Microsoft Outlook, Microsoft PowerPoint, ERP, pH meters, moisture analyzers, refractometers, scales, HACCP, GMP, cGMP, SQF, CAPA, SOPs, Production Batch Records (PBRs), Non-Conformance Reports (NCRs), Critical Control Points (CCPs), Acceptable Quality Level (AQL), CIP, SIP
ZEISS: Produces high-precision optical systems and optoelectronic technologies.
5+ YOEBachelor’s degree in engineering or life sciences, 5+ years in quality assurance, 2 years in medical devices, supplier quality experience, CAPA, process validation, statistical analysis, and regulatory standards knowledge.
Airtech Advanced Materials Group: Manufacturer of vacuum bagging and composite tooling materials.
3+ YOEAA/BS degree in Engineering, Quality, Business, or related field; 3+ years in quality leadership within manufacturing; AS9100/ISO9001 QMS ownership, audit leadership, CAPA, compliance, and team supervision.
AS9100, ISO9001, Microsoft Office, ERP, Dynamics, Navision, CAPA, QMS
Copy of Senior R&D Quality Officer, Product Development Quality Assurance
San Francisco or Irvine
$110k-$209k/yrHybridFull Time
AbbVieNYSE: ABBV: Develops and sells innovative pharmaceutical and biopharmaceutical medicines.
4+ YOEBachelor's degree in a relevant life sciences field; 4–6 years of progressive pharmaceutical QA experience; GMP knowledge; batch record review, TPM oversight, investigations, CAPA, and strong communication skills.
Standard Operating Procedures (SOPs), Electronic batch record, Quality management systems, CAPA, ICH Q7, ICH Q10, 21 CFR Parts 210/211, EU GMP Annexes
ProcessHQ: Provides vertically integrated bioprocess manufacturing solutions and equipment.
5+ YOE3+ Mgmt5+ years in pharmaceutical/biotech regulated industries, 3+ years QA/QC management, experience with CAPA, investigations, validation, audits, cGMP/GDP and ISO 9001 QMS, Bachelor's in a scientific discipline required.
ISO 9001-2015, Quality Management Systems (QMS), cGMP, GDP, CAPA
Salient Motion: Develops modular electromechanical actuation systems for aerospace and defense.
5+ YOEU.S. Person required; bachelor's in engineering or technical field (or equivalent); 5+ years quality experience in aerospace/defense or regulated manufacturing; hands-on AS9100 QMS, audits, CAPA, MRB, and AS9102 FAI experience.
Copy Of Senior R&D Engineer - Medical Device #8994
Marlborough or Irvine
OnsiteFull Time, Contract
ECI: Provides regulatory and engineering consulting for life sciences companies.
5+ YOEBachelor's in engineering (or equivalent experience), 5+ years R&D experience in medical device electromechanical products, strong quality and regulatory knowledge (FDA/ISO), proficiency with quality tools (SPC, DOE, FMEA, CAPA).
Archer: Produces high-protein meat snacks using clean and natural ingredients.
4+ YOERequires 4+ years in an FSQA Supervisor or Lead role at USDA/FDA-regulated facilities, HACCP and/or PCQI certification, expertise in HACCP, FSMA, GFSI, root cause analysis, CAPA, and team leadership; bachelor's preferred.
Quality Engineer III (SSO Division – Location: Irvine, CA)
Irvine, California, United States
$100k-$167k/yrOnsiteFull Time
Parker HannifinNYSE: PH: Manufacturer of motion and control technologies and systems.
5+ YOE5+ years quality experience with a Bachelor’s (or 3+ years with advanced degree). Strong QMS, audit, MRB/CAPA, supplier quality, and problem-solving skills; ISO/AS9100 knowledge and scheme auditor preferred; US citizenship required.
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.
TRIGO ADR Americas: Quality management and supplier assurance services for industrial manufacturers.
3+ YOERequires 3–5 years of quality engineering experience, aerospace manufacturing knowledge, AS9100/ISO 9100, AS9102 FAI, FMEA, SPC, RCCA, CAPA, GD&T, and inspection experience; high school diploma/GED and U.S. citizenship required.
Microsoft Office, Microsoft Excel, Microsoft Outlook, Microsoft PowerPoint, Microsoft Word, FMEA, SPC, RCCA, CAPA, GD&T, FAI, QMS
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)