Shift - M-F 7 am to 4 pm ONSITE
Maternity leave backfill for 6 months
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 Merz North America, Inc.
Represent
Work closely with the Packaging Department 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.
13900 Grandview Parkway, Sturtevant, WI, 53177
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