Quality Engineer
5 months ago
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
1st 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
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