Quality Assurance Specialist

Job Title: Engr 1, Quality

Location: Mannford, OK 74044

Duration: 12 months

Shift: 1st shift 8am-5pm M-Fri

Note:

Interviews - preferably in person

BS Degree or equivalent

Must haves on the resume: GMP experience in med devices and or pharma, Supplier Quality a plus,

**2 years applicable 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