Senior Advanced Quality Engineer

About the role

The Senior Advanced Quality Engineer will lead quality engineering activities for new product development, ensuring the highest level of product and process quality while supporting regulatory compliance.

Key responsibilities

• Develop quality assurance documentation for product development and regulatory submissions.
• Maintain design control processes, identify and correct procedural deficiencies.
• Participate in design reviews, risk management, and verification/validation testing.
• Support Advanced Operations in manufacturing process development and inspection plan creation.
• Lead risk management activities, including risk plans, reviews, and effectiveness verification.

Required profile

• BS in science, engineering or related field; MS, CQE or CRE preferred.
• Minimum 3 years of experience in medical device product development.
• Six Sigma Green or Black Belt preferred.

Required skills

• Failure Modes Effect Analysis (FMEA)
• Geometric Dimensioning & Tolerancing (GD&T)
• Root Cause Analysis and Mistake Proofing (Poka‑Yoke)
• Reading and interpreting CAD drawings
• Statistical analysis using Mini‑Tab or similar tools
• Knowledge of US and International Medical Device Regulations (FDA, etc.)