Quality Inspector INT#26-03463

Franksville, WI

Onsite Job Description

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

•North America, Inc. Represent Work closely with the Manufacturing Depts to provide on-going Quality support. Represent QA at cross-functional meetings, providing input and decision making. Further Tasks Assist with Incoming Inspections, returns and training duties This job description is an overview intended to describe the general nature and level of work being performed by individuals assigned to this job. The descriptions above are not intended to be an exhaustive list of all responsibilities, duties and skills required of the job. All employees may have other duties assigned at any time.