Quality Engineer (Must Have Complaint Investigation, Risk, Root Cause, Post Market)

About the role

Quality Engineering is responsible for product and service quality evaluation and control. Works cross-functionally in the development and or maintenance of products or services.

Responsibilities

• Resolves equipment and process-related production issues, including equipment, process, materials and method validation as well as statistical analysis and metrics to analyze systems and processes being measured.
• Writes test protocols, performs tests, collects data, and writes reports to validate against plans to ensure products are used as intended.

Requirements

• Demonstrates basic knowledge of quality engineering policies, principles and best practices.
• Demonstrates basic knowledge of FDA/ISO requirements.
• Applies basic statistical sample size calculations to work for quality determination on simple projects.
• Applies basic understanding of regulatory requirements (cGMP, FDA, ISO, etc.) to support work with direct supervision.
• Has basic knowledge of theories, practices and procedures in a job family or skill.

Qualifications

• Basic knowledge of quality engineering policies, principles and best practices.
• Basic knowledge of FDA/ISO requirements.
• Basic understanding of regulatory requirements (cGMP, FDA, ISO, etc.).
• Knowledge of statistical sample size calculations.
• Understanding of theories, practices and procedures in a job family or skill.

Skills

• Complaint Investigation
• Risk Analysis
• Root Cause Analysis
• Post Market Surveillance

Benefits

• 6+ Months Duration
• M - F 8am - 5pm Work Schedule

Pay

• Not specified

Schedule

• M - F 8am - 5pm

Benefits

• Not specified