Quality Systems Specialist

This position is responsible for ensuring compliance to Quality Systems training, change control and supporting other quality compliance activities and projects for the Interventional Urology (IU) ID site. This position directly contributes to the efficiency of the Quality Assurance team by building and maintaining strong cross-functional relationships and ensuring conformance to applicable MDR, QS, and other quality requirements.

Major Areas of Accountability:

• Quality Systems Training / Document Control / Compliance
  • Facilitate the timely change, approval and release of product documentation and data (PLM, ERP)
  • Ensure all documents follow appropriate naming and numbering procedures
  • Support development of new product documentation, as required
  • Administer the system for archiving applicable Quality records (both on-site and off-site storage) in accordance with defined requirements and procedures
  • Provide high level customer service and support to specific cross-functional areas
  • Assist in monitoring process effectiveness including the impact of changes and take the initiative to recommend process improvements and ensure procedures are in place to classify and maintain appropriate records
  • Provide user training to change control systems, as directed
  • Support use of the established learning management system (LMS) used to manage direct and indirect labor training for IU ID, including surge support for IU SD
  • Maintain accurate training records, in accordance with applicable regulations and requirements
  • Support IU ID production with direct labor training, as directed
  • Conduct general Quality System training to new employees, as applicable
  • Coordinate and deliver annual Quality System training (i.e., GMP, GDP), as required
  • Monitor training status for the IU ID site – identifying, escalating, and resolving identified risks
  • Report on performance of training process to site level management, as applicable
  • Support internal and external audits, as requested
• General
  • Support production to maintain commercial supply and quickly respond to emerging issues; enable efficient review and update of new product and component documentation
  • Coloplast employees are required to conduct business to the highest ethical and professional standards; comply with applicable laws and regulations, the Advamed Code of Ethics on Interactions with Healthcare Professionals, and company policies.
  • Other duties as assigned and as the business unit evolves

Basic Qualifications:

• Bachelor's degree in a technical field, or 3+ years equivalent experience with high school diploma
• Experience in a medical device development or manufacturing environment
• Experience with Class II and Class III implantable medical devices

Required Knowledge, Skills and Abilities:

• Experience administering within a Learning Management System (LMS)
• Experience administering within a change management system (PLM)
• Knowledge of the principles and best practices of quality system