Description

Own quality engineering complaint investigations, root cause analysis, and corrective action processes for medical devices.

This role is hybrid.

Responsibilities

• Investigate complaint issues and service data to determine risk levels and identify root cause codes.
• Analyze quality inputs (FCA, MDR, complaints) to detect trends and systemic issues.
• Review investigation reports for GMP compliance gaps and develop plans to close them.
• Lead corrective and preventive actions (CAPA) using formal problem-solving tools.
• Drive continuous improvement activities and implement process controls for marketed products.

Required Skills

• 3+ years experience in Quality Engineering or related field.
• Knowledge of 21CFR820 and FDA cGMP requirements.
• Experience with statistical analysis tools, specifically Minitab.
• Ability to read and interpret blueprints and technical drawings.
• Strong analytical problem-solving skills for root cause investigations.
• Proficiency in Word, Excel, PowerPoint, Access, and databases.
• Bachelor's degree in Engineering or related discipline.

Preferred Skills

• Medical device industry experience in quality systems deployment.
• Knowledge of ANSI/ISO/ASQC standards.

Key Skills

Education

Bachelor's degree