Job Description
Quality Engineer
As a Quality Engineer , you will assist with the development of quality systems, procedures and controls to ensure that all medical products consistently meet performance and quality specifications in the Germantown Manufacturing facility. The Quality Engineer is a leader and strong technical resource who quickly and effectively resolves quality problems with internal and external customers and suppliers.
Below Are Additional Duties And Responsibilities
- Generates, communicates, and implements ideas and solutions.
- Demonstrates accuracy and thoroughness in completing tasks timely.
- Looks for ways to improve and promote quality.
- Monitor Corrective Action System (i.e. Customer Complaints, Supplier, Internal)
- Initiate and investigate Customer Complaints according to our internal procedure and standards.
- Record essential information on internal and/or customer-specific documentation, including updating customer portals.
- Perform investigations using Lean, Six Sigma, and statistical methods to support root cause analysis and corrective actions.
- Identify gaps and/or trends in systems or processes.
- Initiate and facilitate the Corrective/Preventative Action process using the appropriate quality tools and input from subject matter experts (SME) to implement sustainable solutions.
- Update Quality documents according to our Change Control procedures, as required.
- Verify corrective action effectiveness.
- Drive Non-Conformance Process
- Evaluate and investigate suspect non-conforming product identified by manufacturing and/or the Quality Lab.
- Initiate containment activities, as necessary, with Customer Service and Shipping Department.
- Recommend disposition of product based on thorough investigation and data-driven feedback.
- Initiate and assist Customer Service with Return Material Authorization (RMA) process.
- Develop re-inspection, sort, and/or rework instructions for Manufacturing Operators, as required.
- Collaborate with customer on issuing waiver or deviation documentation and obtain customer approval, as required.
- Maintain the Quality Management System (QMS).
- Understand ISO 13485 Quality management systems requirements.
- Ensure continuing compliance to both internal processes as well as requirements imposed by certification bodies, regulatory agencies, and specific customer requirements.
- Assist in internal, 2nd party, and 3rd party audits.
- Assist with responses and corrective actions for audit findings.
- Support Product Realization process
- Participate in design review, process planning, and failure mode analysis
- Provide input on evaluation of Key Product Characteristics.
- Provide input on gaging methods and equipment.
- Interpret customer requirements including complex blueprints and GD&T call-outs.
- Review and approve Engineering Change Notifications and Verifications
- Evaluate for feasibility and implement updates to customer requirements into associated product control plans, pFMEA, Inspection documentation and other related documents.
- Incorporate industry standard best practices.
- Incorporate lessons learned.
- Evaluate, submit and track Supplier Change Notices to customers and/or suppliers.
- Any other duties as assigned.
- Manufacturing point of contact for the review and disposition of product quality related questions.
- Approve Medical Device release for shipment, as required.
- Perform batch record reviews for medical device prior to release for shipment.
- Generate Certificate of Analysis, as required.
- Release product in ERP system based on customer and process requirements.
- Support Manufacturing process
- Train Manufacturing and Quality Control personnel on customer requirements, inspection techniques, lessons learned, and rework instructions.
- Manage product inspection and testing activities.
- Obtain customer approvals for all required changes based on Quality Agreements.
- Compile supporting measurement and process performance data, as necessary
- Assemble supporting documentation package and review for completeness and accuracy
- Review and approve production documentation updates according to our Engineering Change Order process.
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