146 capa jobs at 96 companies in Monterey Park, 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.
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
Lubrizol: Produces specialty chemicals and additives for diverse industrial applications.
2+ YOEBachelor's degree and 2+ years in manufacturing, engineering, or industrial quality; medical device experience; expertise in FMEA, CAPA, DOE, SPC, validation, control plans, and quality systems.
Minitab, JMP, Statgraphics, FMEA, CAPA, Design of Experiments (DOE), Statistical Process Control (SPC), PPAP, ISO 13485, CFR Title 21 Part 820, ISO 14971, 5S, Lean, Six Sigma, Fishbone Diagram, 6M, 5 Whys, Control Plans, IQ/OQ/PQ, EU MDR
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.
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.
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
AstraZenecaLondon Stock Exchange: AZN: Researches, develops, and manufactures prescription medicines for major diseases.
5+ YOEBachelor's degree or equivalent experience; 5+ years in a GxP-regulated environment; experience with quality systems, deviations, CAPAs, change controls, controlled documents, risk assessments, SOPs, and quality metrics.
AstraZenecaLondon Stock Exchange: AZN: Global biopharmaceutical developing and manufacturing prescription medicines.
5+ YOEBachelor's degree or equivalent relevant experience; 5+ years in a GxP-regulated environment; experience with deviations, CAPAs, change controls, quality risk assessments, controlled documents, SOPs, and quality metrics.
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
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.
Kindeva Drug Delivery: Develops and manufactures complex pharmaceutical drug delivery systems.
10+ YOE7+ MgmtBachelor's degree in engineering, life sciences, or related technical field; 10+ years in regulated manufacturing; 7+ years managing technical staff; GMP, quality systems, CAPA, Lean/Six Sigma expertise.
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.
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).