Cogmedix

 

The Senior Compliance Engineer ensure compliance to, and continuously improve all Cogmedix processes.  The Senior Compliance Engineer will support all compliance activities throughout the organization at Cogmedix.    

 

Responsibilities:

  1. Under the direction of the Director of Quality and Compliance, the Senior Compliance Engineer will:
    1. Lead by example and promote the criticality of strict adherence to compliance at Cogmedix.
    2. Lead in the training of personnel, including customers and suppliers on Cogmedix compliance standards such as cGMP.
    3. As part of the Cogmedix team, assure all outgoing product is manufactured in a compliant manner.  
    4. Ensure compliance of process qualification/validation and new product introduction processes.
    5. Review the compliance of Control Plans and Device History Records.
    6. Facilitate the Customer Complaint and Internal Audit Processes in collaboration with the Director of Quality and Compliance.
    7. Under the direction of the Director of Quality and Compliance, determine compliance in relation to all procedures and processes to ensure Customer requirements are met. 
    8. Lead the “Back Room” during ISO, Customer, FDA audits/investigations. When necessary, act as scribe for Audit/Investigation activities.
    9. Assist in external / supplier audits as needed.
  2. CAPA and Customer Complaints
    1. As needed, collaborate with all internal groups and customers to help determine root cause of customer issues, Complaints, using various techniques including but not limited to Reenactment, PFMEA, Control Plans, Five Whys, Ishikawa (fishbone) Diagrams, Pareto Analysis, etc
    2. Develop/coordinate corrective action/complaint teams for resolution of customer / product issues.
    3. Provide leadership to CAPA/complaint team to document the root cause and planned actions for all internal and customer issues, within Cogmedix defined systems. 
    4. Ensure that all actions taken have proven to be effective.
  3. Export Controls
    1. Under the guidance of the Quality management ensure compliance will all applicable statutory and regulatory requirements regarding Export Controls.
    2. Establish and maintain all required process and procedures to ensure Export Controls compliance 
  4. Internal Audits
    1. At the direction of the Quality management coordinate, execute and facilitate the Cogmedix Internal Audit Schedule.
    2. Ensure that all scheduled audits are conducted per the schedule.  If any audit cannot be completed within the scheduled timeframe ensure an extension is submitted for approval prior to the due date.
    3. Provide any required training and mentorship for the Internal Auditors.
    4. Ensure that all required documents are completed and upload to Cogmedix defined systems.
    5. Provide follow up on all findings that result from any internal and external audits.
  5. Procedure Review
    1. When appropriate, review and revise procedures related to the Customer Complaint, and Internal Audit processes.
    2. When appropriate and with the direction of the Director of Quality and Compliance, review all quality procedures for compliance to ISO 13485 and FDA 21CFR Part 820.
  6. Metrics
    1. Develop and implement metrics surrounding the Complaint and Internal Auditing, including Audit Finding, processes for monthly, annual and management reviews.
    2. Assist with the establishment of compliance related metrics.
  7. Training
    1. Assist in Compliance training of Cogmedix associates, such as Good Documentation Practices (GDP), Quality System Regulation, etc.
    2. Assist in the training of electronic systems such as E10, Omnify and Aegis.
  8. Other related duties as assigned.

 

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 preferred.
    6. 5 to 10 years’ experience in ISO-13485 certified required and cGMP organizations preferred. The ability to excel in the understanding and interpretation of ISO 13485 and Quality System Regulation FDA / 21 CFR Part 820 and other standards / QSR’s as necessary.
    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. Intermediate 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. Certified Lead Quality Auditor, ISO 13485 preferred or equivalent training with proven auditing experience.
    14. Physical requirements
      1. Standing for prolonged periods of time
      2. Lifting up to 30 pounds