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.

Job Type: Contract

Salary: $27.00 - $29.00 per hour

Expected hours: 40 per week

Benefits:

• Paid time off

Experience level:

• 2 years
• 3 years

Schedule:

• 8 hour shift
• Monday to Friday

Work setting:

• Assembly line
• Manufacturing facility

Education:

• Bachelor's (Required)

Experience:

• Quality inspection: 2 years (Required)
• Batch Record: 3 years (Required)
• Labelling: 3 years (Required)
• IUO and IVD product labeling: 2 years (Required)
• Change Review: 3 years (Required)
• Document Change Control: 3 years (Required)
• Design History Files (DHF): 3 years (Required)
• Device Master Records: 3 years (Required)

Work Location: On the road