63 capa jobs at 39 companies in Encinitas, CA

4d
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Principal Quality Systems Specialist - CAPA
Northridge or Minneapolis or San Diego
$109k-$185k/yr HybridFull Time
MiniMed Group
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.
Trackwise
1mo
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CAPA Engineer
Rancho Santa Margarita, California, United States
$72k-$78k/yr OnsiteFull Time
Applied Medical
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
1mo
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Quality Engineer CAPA & CI
Poway, California, United States
$89k-$156k/yr OnsiteFull Time
General Atomics
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.
PFMEA, AS9100, SAP
2mo
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Senior Associate, QA Compliance
San Diego, California, United States
$99k-$120k/yr OnsiteFull Time
Artiva Biotherapeutics
Artiva BiotherapeuticsNASDAQ: ARTV: Develops allogeneic natural killer cell-based therapies for various diseases.
5+ YOE5+ years in FDA-regulated CGMP; bachelor’s degree; experience with deviations, CAPA, change control, audits.
Quality Management System, CAPA, Deviation tracking, Change control, Document control
2w
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Product Assurance Engineer
San Diego, California, United States
$90k-$120k/yr OnsiteFull Time
Voyager Technologies
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.
AS9100, ISO 9001, MIL-STD, 8D, CAPA
2mo
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Quality Engineer I-1503
Tijuana, Baja California, Mexico
OnsiteFull Time
Protective Industrial Products (PIP)
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
3w
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Quality Assurance Engineer
El Cajon, California, United States
$29-$35/hr OnsiteFull Time
Q Microwave
Q MicrowaveNYSE: APH: Designs and manufactures precision RF and microwave filter solutions.
3+ YOE3+ years quality engineering in electronics/aerospace, Bachelor's in engineering or equivalent, AS9100/ISO9001 knowledge, FAI/AS9102, GD&T, SPC/Cpk, root-cause/CAPA experience, strong communication, U.S. Person (ITAR).
AS9100, ISO 9001, 8D, 5-Why, fishbone analysis, CAPA, AS9102, GD&T (ASME Y14.5), SPC, Cpk, Gage R&R, AS9101, FMEA, AS5553, J-STD-001, IPC-A-610, MIL-STD-202, MIL-STD-883, DPAS
3w
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Staff QA Engineer
San Diego, California, United States
$111k-$185k/yr OnsiteFull Time
Dexcom
DexcomNASDAQ: DXCM: Develops continuous glucose monitoring systems for diabetes management.
8+ YOEExpertise in QMS, nonconforming events, CAPA, audits, dashboard development, statistical analysis, and medical device quality/compliance.
Power BI, Tableau, Oracle, Camstar, IQVIA, 1Factory, EtQ Reliance, SQL Servers, Google Big Query, Minitab, Jump
3d
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QC Analyst
Carlsbad, California, United States
$70k-$130k/yr OnsiteFull Time
Novartis
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.
High-Performance Liquid Chromatography, Ultra Performance Liquid Chromatography, Empower
2mo
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MSAT Associate 2
San Diego, California, United States
$73k-$88k/yr OnsiteFull Time
Capricor Therapeutics
Capricor TherapeuticsNASDAQ: CAPR: Develops cell and exosome therapies for treating rare diseases.
2+ YOEBachelor’s degree and 2+ years of hands-on cGMP biologics manufacturing; experience with adherent cell culture; technical writing; data analysis; deviations/CAPAs; GMP, QA collaboration.
1mo
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QA Associate III
San Diego, California, United States
$30-$33/hr OnsiteFull Time
PCI Pharma Services
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.
Microsoft Office, ERP
3w
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Quality Systems Specialist
Carlsbad, California, United States
$36-$40/hr OnsiteFull Time
Argonaut Manufacturing Services
Argonaut Manufacturing Services: Contract manufacturing organization for biopharmaceutical and diagnostic products.
2+ YOE2+ years QA experience in cGMP environment preferred; Bachelor’s degree or equivalent experience; experience with MasterControl, batch record review, CAPA, deviations, and ISO 13485 compliance.
MasterControl, LIMS, ERP
3d
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Sr/Exec Director, Quality Assurance GCP
San Diego or South San Francisco or United States
$250k-$290k/yr HybridFull Time
Erasca
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.
1mo
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Quality Engineer
Chula Vista, California, United States
$75k-$95k/yr OnsiteFull Time
TDK-Lambda Americas
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
1mo
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Sr. Supplier Quality Engineer I (Contract Manufacturing)
San Diego, California, United States
$100k-$123k/yr HybridFull Time
Tandem Diabetes Care
Tandem Diabetes CareNASDAQ: TNDM: Manufacturer of automated insulin delivery systems for diabetes management.
5+ YOESupplier quality experience in regulated environments; conducting supplier audits, CAPA, quality agreements, PFMEA/DOE/SPC familiarity, GD&T understanding, and ability to drive supplier continuous improvement.
1w
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Manager, Quality Engineer
San Diego, California, United States
$120k-$145k/yr OnsiteFull Time
REVA Medical
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.
Six Sigma, DOE, ASTM, ISO, ICH
2mo
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Manager, Quality Control
San Diego, California, United States
$124k-$161k/yr OnsiteFull Time
Insmed
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.
Labware LIMS, JMP, Chromeleon, HPLC, CE-SDS, ICP-MS, DLS, QMS
3d
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Sr Quality Assurance Specialist
San Diego, California, United States
$108k-$140k/yr OnsiteFull Time
Grifols
GrifolsMadrid Stock Exchange: GRF: Develops plasma-derived medicines and clinical diagnostic solutions.
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
2d
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QUALITY ASSURANCE SPECIALIST
San Diego, California, United States
$85k-$111k/yr OnsiteFull Time
U.S. Navy
U.S. Navy: Conducts maritime defense and provides aircraft maintenance services.
1+ YOEAt least one year specialized QA experience equivalent to GS-09: applying quality/industrial engineering methods, conducting technical analyses, root-cause investigations, CAPA, and quality management reviews.
2w
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Quality QMS Auditor
Santa Catarina or Reynosa or Mexicali or Tijuana
FieldFull Time
Vertiv
VertivNYSE: VRT: Provides critical power and cooling for data centers.
3+ YOE3+ years QMS experience, certified internal auditor, working knowledge of ISO-9001, process-based internal audit experience, RCCA/CAPA capability, strong analytical and communication skills, English proficiency.