Quality Engineer II

1. Position Reports to:
   
   
   1. Director of Quality and Compliance, Cogmedix
      
      
2. Description:

1. Cogmedix is a team of talented and caring associates bringing OEM medical technology to life. Providing turnkey manufacturing services to a broad range of medical and dental OEM’s, Cogmedix delivers high quality products to market with compliance, competence, and commitment. Cogmedix provides a high level of flexibility in product launch and demand management and aligns itself with innovative companies that maintain similar high standards in honesty and integrity. Cogmedix is a subsidiary of Coghlin Companies, Inc., a privately held concept to commercialization firm spanning four generations. Visit Cogmedix and sign up for the e-Newsletter at www.Cogmedix.com.
   
   
2. The Quality Engineer II ensure compliance to, and continuously improve all Cogmedix processes.  The Quality Engineer II will support all compliance activities throughout the organization at Cogmedix.
   
   
3. Responsibilities:
   
   
   1. Under the direction of the Director of Quality and Compliance, the Quality Engineer II will:
      
      
      1. Lead by example and promote the criticality of strict compliance adherence at Cogmedix.
         
         
      2. Lead in the training of personnel, including customers and suppliers on workmanship and quality standards.
         
         
      3. As part of the Cogmedix team, assure all outgoing product is manufactured in a compliant manner.  
         
         
      4. Support process qualification/validation and new product introduction processes.
         
         
      5. Development and execution of Control Plans.
         
         
      6. 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. Support non-conforming material issues resolution with suppliers.
         
         
      5. Collaborate with customer to help determine root cause of customer issues. 
         
         
   3. QC Inspection 
      
      
      1. Provide guidance to the Quality Control inspection process.
         
         
      2. Develop skills as a Trainer to new QC Inspection resources.
         
         
      3. Development of quality and inspection plans.
         
         
   4. Supplier Quality
      
      
      1. Under direction of the Director of Quality and Compliance, assist in the development and execution of supplier audit plans.
         
         
      2. Contribute to the ongoing assessment of current and new potential suppliers.
         
         
      3. Support continuous supplier improvement through collection of data and performing statistical analysis.
         
         
      4. Build strong rapport with customers and suppliers through generating data and presenting quality metrics to meet or exceed mutually defined expectations.
         
         
   5. Production Quality
      
      
      1. A needed, assist Manufacturing Quality Engineers (MQE’s) with manufacturing compliance issues, taking appropriate action within the Cogmedix Quality System.
         
         
      2. Work with Manufacturing Quality Engineers, assembly, production and test to identify trends, propose, and implement corrective actions.
         
         
      3. Collaborate with PM’s and MQE’s to develop optimal work order routings.
         
         
      4. Collaborate with Supply Chain, PM’s and Operations on managing the Material Review Board (MRB) process.
         
         
      5. Performs other responsibilities as directed.
         
         
4. 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. Experience in ISO-13485 certified required and cGMP organizations preferred. 
      
      
   7. 5 years professional experience in medical subassembly and finished device manufacturing required. 6 to 10 years preferred.
      
      
   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.
       
       

Note: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and/or skills required of all personnel so classified.

Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled