Top 4 Quality engineer post market Jobs in Athens, Tx

Senior Quality Engineer
Argon Medical Devices —Athens, TX
- $1 a year
- Full-time
- Bachelor of Science
- 8 years
- Bachelor's degree
- Relocation assistance
- Health insurance
Quick Apply
2d
Senior Quality Engineer
Argon Medical Devices Inc —Athens, TX
- Full-time
- Bachelor of Science
- 8 years
- Bachelor's degree
Quality Engineer - Post Market
Argon Medical Devices Inc —Athens, TX
- Full-time
- Engineering
- 3 years
- Analysis skills
8d

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Senior Quality Engineer

Argon Medical Devices -
Athens, TX

Quick Apply

Job Details

Full-time
$1 a year
2 days ago

Benefits

Relocation assistance
Health insurance
Dental insurance
401(k)
Flexible spending account
Tuition reimbursement
Paid time off
Vision insurance
401(k) matching
Life insurance

Qualifications

Statistics
ISO standards
Bachelor of Science
Statistical Process Control
Bachelor's degree
Biomedical regulatory compliance
Manufacturing

Full Job Description

Argon Medical is a global manufacturer of specialty medical products, headquartered in Plano, Texas. Argon offers a broad line of medical devices for Interventional Radiology, Vascular Surgery, Interventional Cardiology and Oncology. Argon’s brand is recognized for best-in-class products that improve patient outcomes via percutaneous, image-guided procedures. Our values describe what we believe in and how we operate. These values are our moral compass which guide our decisions and define the deeply held beliefs and principles of our organizational culture. Argon Medical is a family of individuals united by a mission and culture which continue to grow stronger every day.

ARGON MEDICAL DEVICES IS NOT LEVERAGING SEARCH FIRMS

Excellent opportunity for a Quality Engineer at our manufacturing facility in Athens, TX!

Location: Athens, TX is 1 hour and 20 minutes southeast of downtown Dallas. It's a rural, peaceful area but a short drive to Dallas or Tyler, TX.

What you will do:

The Sr. Quality Engineer is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support.

Design Controls & Risk Management

Lead and maintain Design Control deliverables: Design & Development Plans, Design Inputs/Outputs, Design Reviews, Traceability Matrix, DHF updates, and DMR readiness.

Test Methods, Measurement & Data Integrity

Develop, validate, and transfer test methods (TMV/MSA: accuracy, precision, repeatability/reproducibility, linearity, bias, gage R&R).
Establish acceptance criteria using sound statistics (e.g., tolerance intervals, confidence levels, sample size determination, DOE when appropriate).
Ensure data integrity (ALCOA+) and compliant documentation in eQMS/PLM systems.

Design Transfer & Process Readiness

Partner with Manufacturing Engineering on process characterization (IQ/OQ/PQ), CTQ definition, control plans, and inspection methods.
Approve FAI for critical components; ensure supplier controls and incoming inspection are aligned to risk.
Lead line readiness for pilot builds and PP events; facilitate defect prevention (Poka‑Yoke, SPC implementation, mistake-proofing).

Regulatory & Standards Compliance

Ensure compliance with 21 CFR 820, ISO 13485, MDSAP, ISO 14971, and applicable standards (IEC 60601, ISO 10993, ISO 11135/11137, ISO 11607, IEC 62366, IEC 62304 for software, etc.).
Provide quality input to regulatory submissions (510(k), PMA, EU Technical File) including verification summaries, risk files, and labeling controls.

Problem Solving & CAPA

Drive root cause analysis (5‑Why, Ishikawa, Fault Tree) and implement CAPA with effectiveness checks.
Lead defect prevention and continuous improvement using Lean/Six Sigma tools (DMAIC, Kaizen, DOE).
Own and facilitate ISO 14971 risk management: hazard identification, risk analyses (FMEA, dFMEA/pFMEA), risk controls, and risk-benefit rationale; ensure linkage to verification/validation and post-market surveillance signals.
Define, review, and approve verification & validation (V&V) protocols and reports (including usability, biocompatibility, sterilization, packaging validation, shelf life, transportation, and software validation as applicable).

Skills for Success

BS Degree required.
8+ years as a Quality Engineer required.
Previous experience in FDA/ISO regulated industry required.
CQE and CQA preferred.

Physical demands & Travel required

Light
5-10% Travel

Job Type: Full-time

Pay: $1.00 per year

Benefits:

401(k)
401(k) matching
Dental insurance
Flexible spending account
Health insurance
Life insurance
Paid time off
Relocation assistance
Tuition reimbursement
Vision insurance

Ability to Relocate:

Athens, TX: Relocate before starting work (Required)

Work Location: In person

Quick Apply

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Quality Engineer - Post Market

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