11 13485 jobs at 8 companies in Houston, TX
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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.
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
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
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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
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
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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Senior Staff Design Quality Engineer
Trumbull or Livingston or Stafford or North Tonawanda
OnsiteFull Time
10+ YOE10+ years quality engineering experience in medical devices (8+ with MS). Requires expertise in design controls, risk management (ISO 14971, FMEA), V&V, QMS (21 CFR 820, ISO 13485), and strong communication/project skills.
Microsoft Excel, Microsoft Word, Microsoft PowerPoint, PPAP, FMEA
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Associate Quality Engineer
Houston, Texas, United States
$51k-$101k/yr OnsiteFull Time
0+ YOEBachelor's in engineering or technical field (or equivalent), 0-2+ years engineering experience, knowledge of FDA/GMP/ISO 13485 & 14971, use of quality tools, Six Sigma/Lean experience preferred, strong communication and statistical/data analysis skills.
FDA, GMP, ISO 13485, ISO 14971, Six Sigma, Lean Manufacturing, QMS, EMS, CAPA
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Auditor, Lead
Houston or Spring
$100k-$115k/yr RemoteFull Time
4+ YOEBachelor's degree, minimum 4 years QC/QA experience, 2+ years in Aviation/Space/Defense, lead auditor authentication (AS9100/AS9120/ISO 9001/14001/13485) and ability to perform and lead onsite audits; strong communication and organizational skills.
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Quality Engineer
Houston, Texas, United States
$61k-$123k/yr OnsiteFull Time
2+ YOEBachelor's in engineering or technical field, 2+ years engineering experience, knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, validation (IQ/OQ/PQ), Lean/Six Sigma/DMAIC, and statistical/data analysis; ASQ CQE preferred.
FDA 21 CFR Part 820, ISO 13485, ISO 14971, IQ/OQ/PQ, TMV, DMAIC, Lean Manufacturing, Six Sigma
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Manager, Manufacturing Engineering
Stafford, Texas, United States
OnsiteFull Time
5+ YOE3+ MgmtBachelor's in Engineering/Technology, 5+ years medical device engineering experience, 3+ years management, Six Sigma/Lean experience, Solid Works/CAD and PLM skills, ISO 13485 knowledge, supplier controls and process validation, English/Spanish fluency preferred.
Microsoft Word, Microsoft Excel, Microsoft Project, Microsoft PowerPoint, PLM system, CAD, Solid Works