Quality Engineer- Richfield, WI

Quality Engineer:

Are you inspired by the ability to make a difference? Now is your chance to work as part of a new project development launch for a large, highly regarded healthcare customer on a program that that makes a difference to our team, our customers and their patients!

Below Are Additional Duties And Responsibilities

• Address customer complaints and internal quality issues.
• Initiate the corrective action process and use the appropriate quality tools to ensure that the problem is satisfactorily resolved.
• Investigate issues and acquire input from subject matter experts.
• Interface with customers.
• Drive the team to implement permanent corrective actions.
• Update production documents including control plan, PFMEA, visual inspection criteria, incoming inspection plan and in process inspection report.
• Record all actions on internal and customer-specific documentation, including updating customer portals.
• Address suspect and non-conforming product.
• Initiate stop-ship and containment activities.
• Initiate RMA process for product in customers possession.
• Recommend disposition of product.
• Develop inspection/sort/rework instructions.
• Develop customer waiver (deviation) documentation and obtain customer approval, if required.
• Maintain the Quality Management System (QMS).
• Understand ISO-9001 Quality management systems Requirements.
• Ensure continuing compliance to both internal processes as well as requirements imposed upon us by certification bodies, regulatory agencies, and specific customer requirements.
• Assist in 2nd party, 3rd party, and internal audits.
• Assist in responses and corrective actions for audit findings.
• Approve product for shipment.
• Perform batch record reviews.
• Generate Certificate of Analysis, as required.
• Release product in ERP system.
• Support engineering change process.
• Interface with customer to ensure compliance to customer request and requirements.
• Manage product inspection and testing activities.
• Update production documents including control plan, PFMEA, visual inspection criteria, incoming inspection plan and in process inspection report.
• Complete required documentation.
• Submit documents to customer and obtain customer approval.
• Support Operations.
• Resolve inspection issues to allow product movement in a timely manner.
• Update production documents when errors are found.
• Train production and QC staff on customer requirements, inspection techniques, and rework instructions.
• Generate quality plans for new product launches
• Incorporate documented customer requirements
• Incorporate industry standard practices
• Incorporate our lessons learned
• Generate and get customer acceptance of an IQ/OQ/PQ protocol
• Develop and validate measurement systems
• Interface with gage & equipment manufactures to ensure understanding of requirements
• Establish validation plans/protocols
• Ensure validation is completed and that all requirements are met (FAT)
• Generate clear instructions for gage end-users
• Perform MSA studies and ensure that Gage R&R is acceptable
• Generate and document golden samples and/or challenge parts
• Obtain customer approval
• Compile measurement and process performance data
• Assemble documentation package
• Review for completeness and accuracy
• Drive correction of all errors
• Submit to customer and drive for approval
• Release production documentation in the document control system
• Transfer knowledge to Operations through reviews and training
• Any other duties as assigned.
• Requirements for Medical Product Focus
• Understand ISO-13485 Medical devices Quality Management Systems Requirements for regulatory purposes.
• Understand 21 CFR Part 820 Quality System Regulation Good Manufacturing Practice for the Medical Devices.
• Understand cleanroom gowning practices and cleanliness requirements for manufacturing within a cleanroom.
• Understand medical customer-specific requirements