w2 role-Quality Engineer
Please apply on this job posting or share resume directly at @pyramidci.
com Role:
Quality Engineer (w2 only) Duration:
12 month Location:
Sparks MD 21152 (Onsite work) Required Background Med Device , Excel, Powerpoint.
Looking for an Engineer with 1-2 years of working experience background in Instrumentation, GMP, ISO DHF Remediation project:
Regulatory is going to pick some higher risk projects that had their 510(k) approved years ago and now due to some issue, they want us to review all the change controls for those platforms and/or look in binders to compile the changes since the 510(k) and then present them to Regulatory Affairs and Quality to make a determination on whether we need to file an amendment to the original 510(k) 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.
Estimated Salary: $20 to $28 per hour based on qualifications.
com Role:
Quality Engineer (w2 only) Duration:
12 month Location:
Sparks MD 21152 (Onsite work) Required Background Med Device , Excel, Powerpoint.
Looking for an Engineer with 1-2 years of working experience background in Instrumentation, GMP, ISO DHF Remediation project:
Regulatory is going to pick some higher risk projects that had their 510(k) approved years ago and now due to some issue, they want us to review all the change controls for those platforms and/or look in binders to compile the changes since the 510(k) and then present them to Regulatory Affairs and Quality to make a determination on whether we need to file an amendment to the original 510(k) 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.
Estimated Salary: $20 to $28 per hour based on qualifications.
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