Under the direction of the Senior Manufacturing Quality Engineer, the Manufacturing Quality Engineer I will (for the assigned product accounts):
Support strict compliance adherence at Cogmedix.
Train personnel, including customers and suppliers on workmanship and quality standards.
Compliantly implement and maintain Cogmedix procedures.
Collaborate with Program Managers, Manufacturing Engineers and other departments to analyze customer ECO’s and ensure effective implementation to the production floor through proper use of the Cogmedix ECO process.
As part of the ECO Process and new proposal review, support the management of the customer BOM structure, creation of part numbers and structuring of Supplier Relationships and costs. Define PP/PA/Phantom, Commodity codes, documentation packages commodity and Work Instruction evaluation.
As part of the ECO Process, support the generation and updating of DMR Indexes to ensure accuracy.
Create complex ECOs.
Ensure 100% ECO implementation accuracy.
Ensure compliance to ECO implementation performance metrics goals.
Effectively interact with customers and internal departments to create value-add propositions.
Working with all internal groups, identify trends and process gaps and suggest and assist in the implementation of corrective actions and process improvements.
Collaborate with internal groups and customers to help determine root cause of customer issues, Complaints, and CAPAs.
Promptly respond to manufacturing floor issues, taking appropriate action within the Cogmedix Quality System and continually building strong rapport with customers and suppliers.
Collaborate with Program Management, Quality, and Operations to develop and approve optimal work order routings and Device History Records.
Preparation of redlined documentation for sign offs.
Draft nonconformance documentation.
Support complex troubleshooting efforts. Generate Rework Instructions.
Assist in the deployment of Lean Manufacturing Cells.
Working with the Quality Department, support the development of quality and inspection plans.
Support regular audits of calibrated tools, tools requiring Preventive Maintenance and perishable floor stock items.
Train Assembly Technicians, Test Technicians and Quality Inspectors on procedures as needed.
MQE support for Scaled Product Launch/transitions.
Generate process validation/qualification documentation (e.g., validation protocols, IQ/OQ/PQ) and implement protocols and completion of reports.
Prepare Process Flows, PFMEA’s, Time Studies and participate Value Stream Mapping.
Evaluate Product Performance Data and Internal Metrics for stability and continuous improvements, utilizing Six Sigma practices where appropriate, including SPC (statistical process control).
Support the development of quality and inspection plans.
Generate Manufacturing Engineering Bulletins to communicate Continuous Improvement Opportunities to customers.
Contribute in DFcx exercises.
Generate Risk analysis, Risk management and Risk reports.
Lead Customer Specific Daily Team Meetings.
Review new customer documentation packages.
Lead, execute and support co-build activities.
Support containment of nonconforming product and draft rework instructions for containment.
Participate in Quarterly Business Review for Manufacturing Quality Engineering department.
Review and approve Equipment enrollment forms for assigned product accounts.
Train Engineering Document Control Specialists.
Support DFcx Engineering programs.
Review and generate procedures of customer processes.
Lead challenge busters.
Generate equipment and fixture updates.
Update procedures as needed.
Generate complex BOM.
Perform other activities as directed.
Positive attitude, self-motivator, and tenacious follow up required.
Superior customer service attitude.
Excellent teamwork, communication, interpersonal and leadership skills.
Exceptional attention to detail.
Strong electro-mechanical and opto-mechanical orientation.
Experience in ISO-13485 certified and cGMP organizations preferred.
Proven problem solver with multitasking skills and the ability to prioritize tasks to align with the goals of the department and organization as a whole.
Knowledge of IPC 610 and 620 standards beneficial.
Advanced ability to read, interpret and understand engineering documentation including assembly drawings, detailed component drawings, optical schematics, electrical schematics, pneumatic schematics, and wire run lists.
Must be able to climb stairs and lift up to 30 lbs.
Associate’s degree in science, engineering, or manufacturing discipline. Four or more years of related manufacturing experience and technical document control may be considered in lieu of certain educational requirements.
2+ year’s professional experience in medical subassembly and finished device manufacturing preferred.
Advanced Level Skills in MS Word, Excel and PowerPoint such as keyboard short cuts, creating forms, table techniques, working with images, text, and pivot tables preferred.
Advanced Level Skills in MS Visio such as creating Visio diagrams, creating custom styles and templates, cross functional flow charts, linking drawings to other MS applications, working with data, custom reports, and exporting is valuable.