Position : Quality Engineer (Must Have Complaint Handling Exp) – Mid Level

Location : Sparks, MD

Duration : 12 Months contract

Total Hours/week : 40.00

Client: Medical Device Company

1^st Shift

Job Category: Engineering

Level Of Experience: Mid-Level

Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only)

Note:

Must have Complaint Handling experience.

Job Description:

• 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.
• The Engineer is involved in resolving the equipment and process-related production issues, activities including equipment, process, materials and method validation as well as statistical analysis and metrics to analyze those systems and processes being measured.
• 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
• Writes test protocol, tests, collects data, and writes reports to validate against plan to ensure product is used as intended
• Has basic knowledge of theories, practices and procedures in a job family or skill Applies knowledge and skills to complete own work Depends on others for instruction, guidance and direction
• Develops competence in own area by performing routine work