Under the direction of the Quality Manager, the Quality Engineer you will:
Lead by example and promote the criticality of strict compliance adherence at Cogmedix.
Assist in the training of personnel, including customers and suppliers on workmanship and quality standards.
As part of the Cogmedix team, assure all outgoing product is manufactured in a compliant manner.
Support process qualification/validation and new product introduction processes.
Development and execution of Control Plans.
Review device history records for quality approval as needed.
Under direction of the Quality Manager, oversee and execute Redline and Engineering Change Notifications (ECN’s) processing. Collaborate with Project Managers (PM’s) to analyze customer ECN’s and ensure effective implementation to the production floor through proper use of the Cogmedix Engineering Change Order (ECO) process, including reviewing and communicating impacts of any changes (e.g., financial, inventory, WIP, open supplier orders, etc.).
Suggest improvements to ECN/ECO process that lead to improved efficiency, accuracy, and quality.
Meet or exceed established ECO implementation performance metrics.
Non-Conformances, Complaints, CAPAs
Drive improvement of Cogmedix Quality through analyzing non-conformances (NC’s) and performing root cause analysis of discrepancies. Propose, review and implement approved corrective and preventive actions
Collaborate with all internal groups and customers to help determine root cause of customer issues, Complaints, and CAPAs using various techniques including but not limited to Reenactment, PFMEA, Control Plans, Five Whys, Ishikawa (fishbone) Diagrams, Pareto Analysis, etc.
Support non-conforming material issues resolution with suppliers.
Collaborate with customer to help determine root cause of customer issues.
Lead the Quality Control inspection process
Develop skills as a Trainer to new QC Inspection resources.
Development of quality and inspection plans.
Under direction of the Quality Manager, Assist in develop and execute supplier audit plans.
Contribute to the ongoing assessment of current and new potential suppliers.
Support continuous supplier improvement through collection of data and performing statistical analysis.
Continually build strong rapport with customers and supplies through data collection and metrics generation.
Promptly respond to manufacturing floor quality issues, taking appropriate action within the Cogmedix Quality System.
Work with Manufacturing Engineers, assembly, production and test to identify trends and propose and implement corrective actions.
Collaborate with PM’s to develop optimal work order routings.
Collaborate with Supply Chain, PM’s and Operations on managing the Material Review Board (MRB) process.
Other duties as assigned.
Positive attitude, self-motivator, and tenacious follow up required.
Superior customer service attitude.
Excellent teamwork, communication, and interpersonal skills.
Bachelor’s degree, preferably in a science or engineering discipline. Significant and applicable professional experience may be considered in lieu of certain educational requirements.
Strong electro-mechanical orientation.
Experience in ISO-13485 certified required and cGMP organizations preferred.
Minimum of 2 years professional experience in medical subassembly and finished device manufacturing. 3 to 5 years preferred. Significant and applicable professional experience may be considered in lieu of medical device requirements.
Proven problem solver.
Knowledge of IPC 610 and 620 standards beneficial.
Advanced Level Skills in MS Word and Excel such as keyboard short cuts, creating macros and forms, table techniques, working with images and text, pivot tables.
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.