43 13485 jobs at 23 companies in Texas
6d
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Quality Engineer I
Austin, Texas, United States
OnsiteFull Time
Bachelor's degree in a scientific or technical field required; no experience required. Knowledge of cGMP, ISO 13485/9001, quality systems, inspections, CAPA, and regulated manufacturing preferred.
TrackWise, SAP, Microsoft Office, Lean, Six Sigma
2mo
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Senior Process Engineer
Stafford, Texas, United States
OnsiteFull Time
7+ YOE7+ years of process engineering in regulated manufacturing; medical device experience preferred; strong FDA QSR/ISO 13485 knowledge; root cause analysis experience.
1mo
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Sr. Engineer
Athens, Texas, United States
OnsiteFull Time
5+ YOEBachelor's in engineering, 5+ years in medical device or regulated manufacturing, experience with NPI, validations, design controls, project management, and regulatory compliance (cGMP, FDA, ISO 13485).
SolidWorks, Microsoft Project, Microsoft Excel, Microsoft Teams, Minitab
2w
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Sustaining Engineer I
Austin, Texas, United States
OnsiteFull Time
4+ YOEBachelor's degree in engineering or 4+ years engineering experience in medical devices/ISO 13485, knowledge of FDA/GMP, DOE/validation, strong problem solving and communication skills.
Microsoft Word, CAD, Microsoft Excel, SolidWorks
1mo
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Microbiologist
Austin, Texas, United States
OnsiteFull Time
1+ YOEBachelor in microbiology or biology and 1+ years relevant experience in medical device or regulated industry; knowledge of sterilization, environmental monitoring, technical writing, ISO 13485 preferred, and Microsoft Office.
Microsoft Office
2mo
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Quality Assurance Manager
Houston, Texas, United States
OnsiteFull Time
3+ YOE3+ years in EN ISO 13485 quality systems; Knowledge of FDA QMSR, MDSAP, EU IVDR; strong analytical, documentation, and audit skills; English proficiency; startup environment experience.
EN ISO 13485, FDA QMSR, MDSAP, EU IVDR
3w
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Quality Assurance Technician Sr (11440)
Austin, Texas, United States
OnsiteFull Time
4+ YOEHigh School Diploma or equivalent with specialized training and/or certification and 4 years relevant experience; experience in QC, inspection, metrology, GD&T, blueprint reading, and ISO 13485 familiarity preferred.
Calipers, micrometers, height gauges, Faro arm
1w
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QA Engineer
Carrollton, Texas, United States
OnsiteFull Time
5+ YOEBachelor's degree in engineering and 5+ years of quality engineering experience in manufacturing. Requires ISO 13485, quality systems, medical core tools, validation, statistical analysis, and problem-solving expertise.
ISO 13485, ISO 9001, TL9000, PFMEA, FMEA, Control Plans, SPC, MSA, Six Sigma
5d
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Staff Validation Engineer
Andover or Telford or Houston or Mississauga
$135k/yr HybridFull Time
3+ YOEMaster's in engineering and 3 years of related experience, or bachelor's and 5 years. Requires regulated testing, validation, root cause analysis, hazard mitigation, technical documentation, and ISO 13485 experience.
ISO 13485
1mo
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Quality Engineer II (55024)
Conroe, Texas, United States
$90k-$105k/yr OnsiteFull Time
3+ YOEBachelor's in Engineering, minimum 3 years manufacturing/quality engineering experience, 3 years in ISO environment, domestic travel 10-20%, familiarity with ISO 9001/13485/FDA QSR preferred.
Visio, TrackWise, SAP, Oracle
2mo
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Manufacturing Engineer, Machine Shop
Austin, Texas, United States
$90k/yr OnsiteFull Time
3+ YOEMinimum 3 years in manufacturing/process engineering for a machine shop; AS9100/ISO 13485/NQA-1; GD&T ASME Y14.5; CNC machining; CAM/CAD tools; develop and maintain procedures.
CNC programming, CAM software, CAD tools, GCode, Mastercam, NX CAM, Fusion 360, SolidWorks, NX, Creo
2mo
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Senior Account Manager- Medical Devices (Remote Employee US, NC, US)
Massachusetts or Pennsylvania or Minnesota or Texas or Arizona or Oregon or California or North Carolina or United States
$123k-$163k/yr RemoteFull Time
15+ YOESenior account manager with deep medical device OEM experience, 15+ years experience, bachelor’s in engineering preferred, knowledge of ISO 13485, contract negotiation, P&L responsibility, strong Excel/PPT skills.
Microsoft Excel, Microsoft PowerPoint
3mo
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Quality Associate II - QMS
Boerne, Texas, United States
$28-$37/hr OnsiteFull Time
3+ YOEBachelor’s degree in science; three years quality experience in medical devices; legal to work in the United States; strong knowledge of ISO 9001, ISO 13485, ISO 14971, and QMSR (21 CFR Part 820).
Microsoft Word, Microsoft Excel, Microsoft Outlook
1mo
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Manager, Regulatory Labeling and Operations
United States or Houston
$120k-$145k/yr RemoteFull Time
8+ YOE8+ years in medical device labeling or regulatory affairs, experience with Class III implantable systems, strong knowledge of FDA/EU MDR/ISO 13485, labeling lifecycle/UDI management, localization and vendor oversight.
MadCap Flare, Adobe Illustrator, Adobe InDesign, Loftware, NiceLabel
1w
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Senior CAPA Specialist
Irving, Texas, United States
$78k-$156k/yr OnsiteFull Time
6+ YOEBachelor's degree or equivalent, 6+ years engineering/technical operational experience, CAPA/quality assurance experience, knowledge of FDA QSR (21 CFR 820), GMP, ISO 13485, strong communication and project leadership skills.
Six Sigma
3w
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Supplier Quality Engineer
El Paso, Texas, United States
OnsiteFull Time
5+ YOEBachelor's in engineering,5+ years supplier quality or supplier development experience,knowledge of medical device regulations (21 CFR 820, ISO 13485, ISO 14971),audit and CAPA experience,strong analytical and communication skills.
21 CFR 820, ISO 13485, ISO 14971, ISO14001, OSHAS18001, PM/VSM, Kaizen, DMAIC, FMEA/FTA, RCA, MSA, SPC, Cp/Cpk/Cpm/Ppk, Hypothesis Testing, ANOVA/DOE/EVOP
1mo
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Quality Engineer
Austin, Texas, United States
$94k-$118k/yr HybridFull Time
6+ YOEB.S. in science/engineering or equivalent; 6+ years in medical diagnostics/CLIA/life sciences with 3+ years in quality; audit experience; knowledge of CLIA/CAP, ISO 13485, FDA QSR; statistical analysis; strong writing and communication.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Electronic Medical Records (EMR)
1mo
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QA Technician (AUSTIN, TX, US, 78727)
Austin, Texas, United States
$54k/yr OnsiteFull Time
1+ YOEReview DHRs for FDA (21 CFR 820) and ISO 13485 compliance; H.S. diploma required (Associate's preferred); 1+ year in FDA-regulated manufacturing; audit and quality certification preferred; Microsoft Windows/Office and Oracle familiarity.
Microsoft Windows, Microsoft Office, Oracle
1w
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Senior CAPA Specialist
Irving, Texas, United States
$78k-$156k/yr OnsiteFull Time
6+ YOEBachelor's preferred, minimum 6 years engineering/technical experience, CAPA and quality assurance experience, knowledge of FDA QSR (21 CFR 820), ISO 13485, Six Sigma/root-cause skills, project leadership and technical writing.
Six Sigma
3w
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Quality Engineer - Complaint Handling (Onsite)
Pearland, Texas, United States
OnsiteFull Time
1+ YOE1+ year medical device quality or complaint handling experience; bachelor\u0002s in engineering or science; knowledge of FDA 21 CFR 803/820, EU MDR, ISO 13485; complaint investigations, CAPA, root cause analysis, regulatory reporting.
eQMS
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