Medical Device Quality Inspector — Documentation & Final Release

Stellent IT LLC; Franksville (WI); On-site; USD 55,000 - 75,000; Full time

Job summary

Merz North America, Inc. is seeking a Quality Inspector in Franksville, WI to support documentation review, final release of Medical Device History Records, and ongoing quality activities within Manufacturing and QA.

You will participate in change control, training records, metrics reporting, and cross-functional QA meetings; ensure compliance with SOPs and regulatory requirements, and assist with continuous improvement initiatives across the QA and Manufacturing teams.

Responsibilities

• 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 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

Job description

Merz North America, Inc. is seeking a Quality Inspector in Franksville, WI to support documentation review, final release of Medical Device History Records, and ongoing quality activities within Manufacturing and QA.

You will participate in change control, training records, metrics reporting, and cross-functional QA meetings; ensure compliance with SOPs and regulatory requirements, and assist with continuous improvement initiatives across the QA and Manufacturing teams.