Quality Engineer , Complaints - Onsite

Position:
Quality Engineer 1, Complaints

Location:
Sumter, SC

Duration: 7 Months

Total Hours/week: 40.00

Shift: 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)

• Bachelor's required. Regulatory experience, Excel, macros, trackwise, SAP, Minitab, root cause analysis, Fishbone Diagram, great comm skills. Experience 6 months to 2.5 years.
• 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.