Cogmedix

The Training Manager reports to the Director of Quality & Compliance. The Training Manager manages the training program execution, reporting, and continuous improvement at Cogmedix. The Training Manager will assist the business by assessing the effectiveness of current training programs and work to enhance training for the workforce. Will facilitate and supervise new hire training programs. In addition, the Training Manager will support activities related to the control of Documents and Records maintained by Cogmedix. (Document Control duties include: Ensure that all device history records produced by Cogmedix meet defined expectations.  Work to resolve all discrepancies found during the review prior to approval of the device history records and subsequent release of product.)

Responsibilities:

  • The Training Manager will have an area of excellence that will focus on primary responsibilities e.g. inspection, test, document control, CAPA etc. The Training Manager will also cross train in other areas of the quality organization to strengthen core competencies as a Quality Associate.
  • The Training Manager supports the Quality management to achieve Quality Department objectives and goals by providing administrative assistance.  
    1. Training
  • Prepare and deliver curriculum as necessary to support Cogmedix training needs.
  • Assist in providing Training Plan / Job Description for employees.
  • File training logs within Omnify upon completion of training.
  • Create training within Omnify as required.
  • Must be proficient in the use of the Omnify Training module.
  • Collaborate with business managers to ensure training plans are adequate to meet requirements and training content is effective.
  • Set standards for training materials, delivery of training, and recording of training.
  • Maintain, organize and track employee training plans so that they are consistent with roles and responsibilities.
  • Manage course logistics, including scheduling and publication of training classes and opportunities.
  • Provide routine reporting on training status and training improvement programs.
  • Assist in the development and delivery of training materials as appropriate.
  • Work with department managers to identify department specific training opportunities thru local and state funded grants (i.e. grant based training on supply chain strategies).
  • Work closely with other document management functions to assure objectives are set for associates and other individuals. 
  1. Responsible for following Cogmedix’s Quality Management System, cGMP’s and ISO13485 requirements.
  2. Understands and follows good documentation practices in a cGMP and ISO 13485 environment.
  3. Organize and review Device History Records (DHR’s) at the completion of the manufacturing cycle and ensures all signatures and data are present prior to final approval. Scan DHR’s, save electronically, and upload to FTP sites. 
  4. Update Quality Manuals as needed.
  5. Assist in coordinating and preparing monthly Quality Metrics as well as metrics needs for Management Review. 
  6. Perform all Quality Department administrative functions as required. 
  7. Assist with all notified body, FDA, Internal and/or customer audit related activities.
  8. Scan Design History Files (DHF), to save electronically and upload to customer FTP sites.
  9. Coordinate with Quality management on quality problems relating to the product, process and Quality System.
  10. Perform other activities as directed.

Essential Requirements:

  • 5+ years’ experience in training and development management.
  • 5+ years’ office experience, preferably in a medical device manufacturing organization.
  • Demonstrated track record in developing and executing successful training programs.
  • Familiar with traditional and modern training processes.
  • Highly computer literate with proficiency in MS Office and related business communication tools.
  • Working knowledge of cGMP, QSR, ISO, SOP’s, work rules and safety guidelines preferred.
  • Exceptional organizational and time management skills.
  • Meticulous attention to detail.
  • Effective communication skills, both written and verbal. Must be able to read, write and comprehend English. 
  • Positive customer service attitude, self-motivator, with tenacious follow up. 
  • Excellent teamwork, communication, and interpersonal skills.  
  • Critical thinker with innovative problem solving skills and a strategic and creative mindset.
  • A demonstrated commitment to company values.  

Physical Requirements:

  • Must have a reliable form of transportation and ability to travel to other company locations.
  • Flexibility to work extended hours when needed.