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
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.
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.
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
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
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
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.
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.
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
ICU MedicalNasdaq: ICUI: Develops and manufactures medical devices for infusion and critical care.
7+ YOEBachelor's degree in engineering or related field and 7 years of experience. Requires medical device quality expertise, ISO and FDA regulations, quality systems, design controls, risk management, CAPA, audits, and statistical analysis.
ISO 13485, ISO 14971, FDA QSR, REACH, RoHS, CAPA, Design History Files, Device Master Records, 510K, Technical File, DFMEA, PFMEA
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.
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
Giga Energy: Manufactures electrical infrastructure and operates modular AI data centers.
5+ YOE5+ years manufacturing engineering or supplier industrialization experience with metal enclosures, busbars, or switchboard assembly; SOPs, APQP/PPAP/FAI, SCAR/8D/CAPA, AQL; able to read schematics, GD&T, BOMs; comfortable working with Mexico contract manufacturers and traveling regularly.
Collectors: Providing authentication and grading services for high-value collectibles.
7+ YOE7+ years in quality management or quality-focused program management; hands-on with root cause analysis, CAPA, FMEA, SPC, Lean/Six Sigma; strong data analysis and dashboarding skills; ability to lead cross-functional programs; bachelor's degree in engineering/operations preferred; up to 20% travel and valid passport required.
Lean, Six Sigma, Kaizen, FMEA, CAPA, statistical process control, business intelligence (BI) tools