Quality Engineer - Onsite (Exp in Medical Device Industry)

Position : Quality Engineer – Onsite (Exp in Manufaturing & Medical Device)

Location : Irvine, CA

Duration : 12 Months

Total Hours/week : 40.00

1st Shift

Client : Medical Devices Company

Level of Experience : Entry Level

Employment Type : Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT

Job Description:

• Quality Engineering is responsible for product and service quality evaluation, complaints, 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. Conducts complaint investigations and complaint Engineering Evaluations, assists in the investigation. Effective verbal and written communication skills.
• 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

General Expectations:

• Excellent communication skills working with cross functional teams.
• Perform root cause failure mode assessment for electronic devices.
• Execute Engineering Evaluations for complaint closure.
• Onsite work