Quality Engineer [Must have Complaint Handling exp]

Position Overview

I’m looking for a quality engineer that has complaint handling experience (bonus if it’s medical device or in vitro diagnostics).

Responsibilities

• Works cross-functionally in the development and/or maintenance of products or services.
• Resolves equipment and process-related production issues, including equipment, process, materials, and method validation.
• Performs statistical analysis and metrics to evaluate systems and processes.
• Writes test protocols, conducts tests, collects data, and writes reports to validate against plans.
• Applies basic understanding of regulatory requirements such as cGMP, FDA, ISO, etc.

Requirements

• Complaint handling experience.
• Bonus for experience in medical device or in vitro diagnostics.

Qualifications

• Basic knowledge of quality engineering policies, principles, and best practices.
• Basic knowledge of FDA/ISO requirements.
• Ability to perform basic statistical sample size calculations.
• Basic understanding of regulatory requirements.
• Knowledge of theories, practices, and procedures in quality engineering.

Benefits

• Onsite daily.
• 12+ Months Contract.
• M-F 8am - 5pm work schedule.

Pay

TBD

Schedule

M-F 8am - 5pm

Benefits

Onsite daily