Job Title:

Quality Inspector /

Quality Assurance Location:

Sturtevant, WI 53177

Duration:

12+ Months - (Possible extension/Potential to convert to FTE)

Job Overview:

Documentation Review Ensure timely QA review of documentation to verify compliance to SOP's and regulatory requirements. Perform final review and release of finished Medical Device History Records. Identify and initiate NCA for nonconformance found during the final review of DHR's. Maintain expertise in quality systems (e.g. assist and review SOP's, initiate change control) Ensure training requirements are met and records are up to date. Maintain and update departmental metrics and required reports. Assist with continuous improvement initiatives / projects within the Manufacturing and Quality departments.

KEY RESPONSIBILITIES

Processing the field inquiries received by phone, electronic or verbal correspondence in accordance to applicable SOP(s). Will also be responsible for reviewing complaint records to ensure the records are completed in accordance with global regulations and internal procedures. Provide technical support and remote troubleshooting guidance as needed. Conduct follow-up activities to be able to close records in a timely manner. Complete investigations which may include execution of product returns and subsequent evaluations, reviews of manufacturing records, and assuring proper approvals are obtained as part of closures. Execute the activities of processing complaints in accordance with the Company Quality System.

Pay:

$22.00 - $24.00 per hour

Experience:

Quality inspection: 3 years (Required)

QA/QC:

3 years (Preferred) Quality assurance: 2 years (Preferred) pharmaceutical / medical: 2 years (Preferred)

Work Location:

In person