Quality Engineer(Medical Devices)

Hi,

Hope you are doing well,

This is Kalpana, the recruiter from Intellect; we have openings forQuality System Engineer IIwith our direct client in the locationAtlanta, GA – 30313if you are looking for any job change, please check the job description and if you are interested call me at 732-832-3282 or email me [email protected]

Role: Quality System Engineer II

Location: Atlanta, GA - 30313

Duration: 12 Months on W2

Shift Timings: 8 AM to 4 PM

Main Purpose of the Role:

·Provide Process/Quality Engineering support to manufacturing, helping to ensure delivery of highest quality product to the customer. Provide Process/Quality Engineering support to product development teams, helping to ensuredevelopmentofhighestqualitynewproducts

Main Responsibilities:

·Identifies and controls Manufacturing process defects (scrap, nonconforming material, customer complaints) by participating in efforts/teams focused on identifying the primary root causes and implementing corrective and preventative actions.

·May be responsible for querying & bounding data to support implementation of complex & documenting release criteria.

·Validate the integrity, validity, and quality of the data across all data platform components;

·Develops product quality plans, documents and systems by creating product specifications, quality specifications and quality plans in conjunction with other product development team members.

·May be responsible for creating risk analyses and FMEAs.

·Develops Process Monitoring Systems by identifying critical process steps applying methods to reduce process variation in order to reduce/eliminate the cause of defects.

·Leads process improvement efforts by identifying methods to capture quality metric data and by performing appropriate analysis methods to enhance sustaining product design and new product development. Leads validation initiatives

·Assists in creation of Quality Tools & Training Materials by understanding the limitations of existing quality tools and training materials, and by helping to identify more effective tools & materials.

·Cultivates a wide range of internal networks and begins to develop an extensive external network of resources to facilitate completion of tasks.

·May lead a project team of moderate scope.

·Provides guidance to less experienced staff.

·Acts as a mentor to lower-level individual contributors.

·Influence exerted at peer level and occasionally at first levels of management.

·Plans, organizes, and prioritizes own daily work routine to meet established schedule.

·Exercises authority and judgment within defined limits to determine appropriate action.

·Failure to achieve results or erroneous decisions or recommendations may cause delays in program schedulesand mayresult intheallocation ofadditionalresources.

Experience/Back ground:

·Related work experience with a good understanding of specified functional area.

·Working technical knowledge and application of concepts, practices and procedures. General understanding of business unit/group function.

·Will perform this job in a quality system environment.

·Failure to adequately perform tasks can result in noncompliance with governmental regulations.

·Works on problems of moderate scope where analysis of situations or data requires a review of identifiable factors.

·Exercises judgment within defined procedures and practices to determine appropriate action.

·Has a broad knowledge of technical alternatives and an understanding of their impact on the systems environment.

·A bachelor’s degree in computer science preferably, or any other discipline (optional). Experience writing SQL queries and python. Knowledge of working with huge, diversified data sets in a big data setting