CareerPlan

Sr. Quality Engineer

Durham, NC, usFull-time2026-11-05 → 2026-11-10
U.S. persons only (export control)

Core

Sr. Quality Engineer enabling the Advanced Tissue Models team to establish optimum quality control in product manufacturing and design control for porcine-derived and synthetic surgical training tissue models.

Role type

Senior IC Quality Engineer (Medical Devices)

Builds

Porcine-derived and synthetic surgical training tissue models and supporting equipment

Domain

Medical Devices / Surgical Training

Required skills

21 CFR 820, ISO 13485, ISO 14971, Design Controls, Risk Management (FMEA), Process Validation, Root Cause Analysis, SPC, Six Sigma (DMAIC), Failure Analysis

Preferred skills

Advanced degree in Engineering/Life Sciences

Technologies

Excel (Pareto, charts, trends), Engineering Change Orders

Responsibilities

Support new product development design controls and risk management; Support manufacturing processes, failure analysis, and defect containment; Lead quality initiatives and continuous improvement projects; Support internal and external audits; Perform deep technical failure analysis based on physics of failure.

Seniority

Senior, hands-on IC