Medical Device Quality Engineer

THIS IS NOT A QA TESTER/SDET ROLE

W2 ONLY

Hiring: Senior Quality Engineer - Medical Device

Location: Fort Worth, TX (100% Onsite)

Type: W2 Contract: Duration: 14+ Months

We are looking for a Quality Engineer II to support a leading medical device manufacturing environment focused on single-use disposable surgical tools and sterilized products.

Key Skills:

✔️ CAPA Management

✔️ Root Cause Investigation & Problem Solving

✔️ NCMR Disposition

✔️ Process Validation & Test Method Validation

✔️ Lean Six Sigma Methodologies

✔️ Statistical Analysis & Quality Improvement

Responsibilities:

🔹 Lead investigations, root cause analysis, and CAPA activities

🔹 Support process and test method validations

🔹 Review and disposition non-conforming materials (NCMR)

🔹 Collaborate with Manufacturing and Engineering teams to ensure product quality and compliance

🔹 Analyze quality data and implement continuous improvement initiatives

🔹 Maintain quality documentation in compliance with regulatory requirements

Preferred Qualifications:

* Experience in Medical Devices or other highly regulated industries

* Knowledge of Lean Six Sigma tools and methodologies

* Experience with Statistical Analysis and Quality Metrics

* ASQ CQE/CQA Certification preferred

* Strong technical communication and documentation skills

Requirements:

* Bachelor''s Degree in Engineering or related field

* 2+ years of Quality Engineering experience

* Ability to work independently in a fast-paced manufacturing environment