Looking for Quality Engineer - Sparks, MD

Position: Quality Engineer

Location: Sparks, MD

Duration: 6+ Months Contract

Total Hours/week: 40.00

Client: Medical Device Company

Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only)

No H1B's

Work days/hours: M - F 9am - 5pm

Local Candidates

On site

Required Background Med Device , Excel, Powerpoint.

Looking for an Engineer with 1-2 years of working experience background in Instrumentation, GMP, ISO.

"DHF Remediation Effort" 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)

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