QA Specialist

Hello Everyone,

Greetings of the day.

This is Vydehi from Intellectt Inc. We currently have an opening for a QA Specialist II with one of our medical device clients. If you or anyone you know is interested in this opportunity, please feel free to send your updated resume to vydehi@intellectt.com or reach out to me directly at 1 732 355 7412.

Role: QA Specialist II

Location: Des Plaines, IL

Duration: 12 Months

Shift Timings: 8 am to 5 pm

Job Description

• Assures the quality of manufactured products and processes per standard operating processes(SOP'S) and GMP (Good Manufacturing Practices).
• BS degree or 3-7 years equivalent experience
  
  

Main Responsibilities

• Familiar and capable of performing all responsibilities of the Quality Associate.
• Subject Matter Expert in one or more specific Quality processes such as incoming inspection and/or change management and/or records (including batch release).
• Also support record administration and batch record review, including Certificate of Analysis / Certificate of Conformance creation for material lot release.
• Assign labeling and pre-production change requests to Change Management staff aligning experience with project load and complexity.
• Process IUO and IVD product labeling and the associated RMS change requests while ensuring compliance with company policies and procedures.
• Able to navigate complexity and troubleshoot issues with the most complex changes
• Assist labeling change owners and junior staff with the creation of design change plans.
• Able to leverage subject matter expertise to impart positive impacts on organizational outcomes.
• Support change packets per the approved procedures, including analyze change packets for impact to Device Master Records and for the associated maintenance of the DMRs.
• Able to independently correct issues and proactively identify future issues.
• Leverage expertise to improve future submissions via collaboration with change owners
• Create and maintain the Design History Files per the approved procedures.
• Review records for good DHF documentation practices and adherence to the DHF Document Change Control requirements.
• Maintain the Master Action Item List, DHF Index and the DHF History Index.
• Assist in the documentation of key processes and departmental procedures and well as participates on continuous improvement projects as assigned.
• Compiles and maintains data used for the creation of department metrics and reports.
• Able to own key local reporting responsibility and take the lead in areas of expertise, as appropriate