The Senior Quality Engineer ensures compliance to, and continuously improve all Cogmedix processes.  As a Quality Engineering leader, the Senior Quality Engineer will manage and oversee Quality Engineering activities along with ensuring compliance within Cogmedix Quality Systems, 21 CFR 820.30 and ISO 13485.  The Senior Manufacturing Engineer will drive continuous improvement quality processes on their individually assigned product accounts in addition to overall Quality Management System. .


    1. Under the direction of the Director of Quality and Compliance, the Senior Quality Engineer will:
      1. Lead by example and promote the criticality of strict compliance adherence at Cogmedix.
      2. Mentor less experienced Quality Engineers and provide guidance in their development.
      3. Lead in the training of personnel, including customers and suppliers on workmanship and quality standards.
      4. As part of the Cogmedix team, assure all outgoing product is manufactured in a compliant manner.  
      5. Support process qualification/validation and new product introduction processes.
      6. Development and execution of Control Plans.
      7. Build strong rapport with customers and suppliers through generating data and presenting quality metrics to meet or exceed mutually defined expectations.  The metrics shall include First Pass Yield (FPY), Nonconformance, Martial Review Board trends, On Time Delivery and other metrics as required by the customer.  The metric support will be based on customer requirements but may include weekly, monthly or quarterly business reviews.
      8. Review device history records for quality approval as needed.
    2. Complaints, CAPAs
      1. Under the direction of the Director of Quality and Compliance, help manage the Customer Complaint and CAPA systems.
      2. Propose, review and implement approved Corrective and Preventive actions. 
      3. 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. 
      4. Provide oversight of all containment activities associated with potentially discrepant material identified through the Nonconforming Material, CA, and Compliant processes.
      5. Collaborate with customer to help determine root cause of customer issues. 
    3. QC Inspection 
      1. Provide Subject Matter Expert oversight to the Quality Control inspection process for assigned product lines.
      2. Proven skills as a Trainer for new QC Inspection resources, as well as training all QC inspection specialist when changes are made to affected processes.
      3. Development and maintenance of quality inspection plans.
    4. ECN/ECO Related
      1. Under direction of the Quality Management, provide support in the form of review and approval for Redline and Engineering Change Notifications (ECN’s) processing. 
      2. Suggest improvements to ECN/ECO process that lead to improved efficiency, accuracy, and quality.
      3. Meet or exceed established ECO implementation performance metrics. 
    5. Supplier Quality
      1. Assist in the development and execution of supplier quality plans.
      2. Frist Article Review and Approval
      3. Contribute to the ongoing assessment of current and potential suppliers.
      4. Lead continuous supplier improvement through collection of data and performing statistical analysis.
    6. Production Quality
      1. As needed, assist Manufacturing Engineers (ME’s) with manufacturing compliance issues, taking appropriate action within the Cogmedix Quality System.
      2. Responsible for communication of quality related issues to the production team.  This communication should be documented in the form of Quality Alerts. 
      3. As the quality representative on the product Success Team, review and approve all RMA’s within Omnify.
      4. Development and maintenance of Quality Forms, and QC Procedures, as needed, for assigned product lines.
      5. Work with ME’s, assembly, production and test to identify trends, propose, and implement corrective actions.
      6. Collaborate with Program Managers (PM’s) and ME’s to develop optimal work order routings.
      7. Collaborate with Supply Chain, PM’s and Operations on the Material Review Board (MRB) process.
      8. During the Scaled Product Launch (SPL) provide Quality support to the success team.  As new products are transferred to Cogmedix support Co-Build activities to ensure that inspection points are clearly defines and understood.
      9. As part of the product success team any qualification of the manufacturing will require quality review and approval of Validation Protocols and Reports.
      10. Performs other responsibilities as directed.

Essential Requirements:  

  1. Positive attitude, self-motivator, and tenacious follow up required.
  2. Superior customer service attitude.
  3. Excellent teamwork, communication, and interpersonal skills. 
  4. Bachelor’s degree, preferably in a science or engineering discipline.  Significant and applicable professional experience may be considered in lieu of certain educational requirements.
  5. Strong electro-mechanical orientation.
  6. Proven experience in ISO-13485 certified organizations required and cGMP . 
  7. 10 + years professional experience in medical subassembly and finished device manufacturing required. 
  8. Certified Quality Engineer (CQE) preferred.
  9. Proven problem solver.
  10. Knowledge of IPC 610 and 620 standards required. Certified training beneficial.
  11. 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.
  12. 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.
  13. Standing for prolonged periods of time.
  14. Ability to lift up to 30 pounds.