Quality Engineer
Job in
Bellevue, Sarpy County, Nebraska, 68123, USA
Listed on 2026-03-06
Listing for:
Unicon Pharma Inc
Full Time
position Listed on 2026-03-06
Job specializations:
-
Engineering
Quality Engineering, Process Engineer, Biomedical Engineer -
Quality Assurance - QA/QC
Quality Engineering
Job Description & How to Apply Below
The Quality Engineer II supports new product development and sustaining engineering for medical devices by applying core quality engineering tools and ensuring compliance with design control, regulatory, and corporate quality requirements. The role partners with cross-functional teams to analyze processes, drive continuous improvement, support validations, and resolve quality issues through data-driven methods.
Key Responsibilities- Provide quality engineering support for product development and sustaining projects.
- Apply tools such as root cause analysis, FMEA, risk management, DOE, validation, MSA, and control plans.
- Ensure compliance with quality policies, procedures, and regulatory standards.
- Review/approve validation and change‑control protocols and reports.
- Monitor process performance and lead continuous improvement using Lean/Six Sigma.
- B.S. in Engineering (Industrial, Mechanical, or similar).
- 3+ years of quality engineering and validation experience.
- Strong statistical/problem-solving skills; proficiency in Minitab and MS Office.
- Solid understanding of medical-device quality and validation principles.
- Experience with failure analysis, test methods, and tolerances.
- Knowledge of 21 CFR 820/210/211 and ISO 13485.
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