General Atomics: Designs and manufactures unmanned aircraft and nuclear technology systems.
4+ YOEBachelor's or master's in engineering with 4–6+ years engineering experience, ability to obtain DoD Secret clearance, leadership, root cause analysis, PFMEA, SAP experience, strong communication and project management skills.
Design Quality Assurance Engineer CAPA- Medical Device #3067
San Diego, California, United States
RemoteFull Time, Contract
ECI: Provides regulatory and engineering consulting for life sciences companies.
8+ YOEBachelor’s or master’s degree in engineering, life sciences, or quality management; 8+ years in medical device design quality; regulatory, design control, risk management, DHF, and submission experience.
Protective Industrial Products (PIP): Global provider of personal protective equipment and safety products.
Industrial/Quality engineering; experience with quality systems ISO 9001 and IATF 16949; internal audits; quality tools (8D, CAPA, FMEA, SPC); English (intermediate/advanced); MS Office.
Quality management systems (ISO 9001, IATF 16949), 8D, CAPA, FMEA, SPC, Microsoft Office
Voyager TechnologiesNYSE: VOYG: Provides advanced defense and commercial space technology solutions.
5+ YOEMaintain AS9100 QMS, perform inspections and supplier audits, manage NCR/CAPA and root-cause analysis, familiarity with MIL-STD/NASA/MDA, ability to obtain U.S. security clearances.
Argonaut Manufacturing Services: Contract manufacturing organization for biopharmaceutical and diagnostic products.
10+ YOE10+ MgmtBachelor's, master's, or Ph.D. in life science; 10+ years of leadership experience in medical device or pharmaceutical industries; FDA-regulated audit, GMP, ISO, validation, CAPA, and team leadership experience.
SOPs, ISO 13485, ISO 14971, GMP, GLP, QSR, ICH Q1A, ICH Q2, 21 CFR 820.30, CAPA, FDA
Merck KGaAFrankfurt Stock Exchange: MRK: Develops pharmaceutical, life science, and electronics technologies.
7+ YOEBachelor’s degree plus 9+ years or master’s degree plus 7+ years in GLP/GMP analytical environments; expertise in quality control, analytical methods, data review, technical writing, CAPAs, and regulatory compliance.
Mesa LabsNASDAQ: MLAB: Manufactures life science tools and critical quality control solutions.
8+ YOE4+ MgmtBachelor's degree in a relevant field; 8–10 years in Quality Assurance or Regulatory Affairs, including 4–5 years managing people. Requires QMS, regulatory compliance, audits, CAPA, analytical, and communication skills.
Quality Management System (QMS), Corrective and Preventive Action (CAPA)
Sunnyvale or Washington, D.C. or San Diego or Fort Walton Beach or Ann Arbor or London or Stuttgart or Munich or Stockholm or Bengaluru or Seoul or Tokyo
$150k-$200k/yrOnsiteFull Time
Applied Intuition: Developing software and simulation infrastructure for autonomous vehicles.
7+ YOE7+ years in operational compliance, transportation safety, program management, or related work, including 3+ years in a safety-critical or regulated environment; experience owning compliance frameworks, RCA, CAPA, and audit-ready records.
ISO 26262, SOTIF, UL 4600, DOT, FMCSA, OSHA, MSHA, CAPA, RCA
NovartisNew York Stock Exchange: NVS: Develops and manufactures innovative prescription medicines for patients.
Bachelor's in chemistry/biochemistry/microbiology, experience in FDA-regulated pharmaceutical analytical testing, knowledge of GMP and data integrity, HPLC/UPLC experience, deviation/CAPA experience.
PCI Pharma Services: Integrated pharmaceutical development, manufacturing, and global packaging services.
3+ YOE3+ years GMP QA experience, HS required (bachelor's in Life Sciences preferred). Knowledge of cGMP, documentation review, investigations, audits, CAPA, and Microsoft Office required.
ErascaNASDAQ: ERAS: Developing precision oncology medicines to treat cancer patients.
12+ YOE12+ years in GCP quality with regulatory inspection experience; demonstrated leadership in clinical QA, knowledge of ICH GCP and global regulations, ability to manage audits, CAPAs, and mentor staff.
NovartisSIX Swiss Exchange, NYSE: NOVN, NVS: A global pharmaceutical focused on developing and manufacturing medicines.
Bachelor's in chemistry/biochemistry/microbiology or related, experience in FDA-regulated pharmaceutical analytical testing, HPLC/UPLC experience, data integrity and GMP knowledge, deviation/CAPA investigation, equipment calibration.
REVA Medical: Develops bioresorbable vascular scaffolds for treating artery disease.
5+ YOEBachelor's in engineering,5+ years medical device/ISO or cGMP experience,catheter/device experience,complaint/CAPA and validation experience,statistical methods (Six Sigma,DOE),ASQ preferred.
TDK-Lambda Americas: Manufacturer of industrial and medical power supply solutions.
5+ YOEB.S. in engineering or equivalent plus 5+ years in quality assurance; foundational electronics knowledge; experience with ISO 9001, QMS, failure analysis, CAPA; strong communication and MS Office skills.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint
InsmedNasdaq: INSM: Global biopharmaceutical developing therapies for serious, rare diseases.
7+ YOEBachelor's degree and 7+ years QC experience in GMP environment; expertise with HPLC, CE-SDS, ICP-MS, method qualification/validation, SOPs, investigations (OOS/OOT/CAPA), and lab management.
5+ YOEBachelor's in biology/chemistry/biochemistry/biomedical engineering, 5+ years quality experience (3–6 with master’s), complaint/CAPA/OOT experience, audit and investigation skills, SAP/Salesforce and Excel proficiency.
SAP, Salesforce, Microsoft Word, Microsoft Excel, Power Point
ResMedNew York Stock Exchange: RMD: Developing cloud-connected medical devices for sleep and respiratory care.
3+ YOEDegree in engineering with 3–5+ years experience, advanced knowledge of FDA design controls and IEC 62304, risk management, audits, CAPA/NCR experience, and proficiency with AI tools and software QA tools.
VS Code, GitHub Copilot, ChatGPT, JIRA, Confluence