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Senior Quality Systems Specialist

Location: 

Minneapolis, US

Job Family:  Quality Assurance
Country/Region:  United States
 

Job Function Summary:

This position is responsible for ensuring compliance to Quality Systems training, change control and supporting or leading 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 Training / Document Control / Compliance
    • 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
    • Ensure QS training processes are documented and controlled, ensuring alignment between corporate & local procedures, and promoting harmonization & continuous improvement
    • 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
    • Look for trends and seek resolution for root cause of common issues
    • Report on performance of training process to site level management, as applicable
    • Support processing of Change Requests and other change management duties for the IU ID site, including surge support for IU SD, as needed
    • Contribute to improvement of the change request process
    • Support implementation of corporate strategic initiatives at site & business unit level, as directed
    • Define and execute projects to improve efficiency, effectiveness, and compliance
    • 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
    • Conform with Coloplast Code of Conduct and all local Compliance Standards
    • Conform with Coloplast Q/EHS Policy
    • Other duties as assigned and as the business unit evolves

 

Basic Qualifications:

  • Bachelor's degree in a technical field, or 5-7 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:

  • Advanced experience administering within a Learning Management System (LMS)
  • Experience administering within a change management system (PLM)
  • High level knowledge of the principles and best practices of quality systems training, change management, and quality compliance
  • Knowledge of FDA, ISO 13485, EU MDR, and related quality system regulations
  • Proficient in oral and written communication skills
  • Ability to train wide variety of audiences on new processes and/or system improvements
  • Customer service focused with the ability to support a variety of levels cross-functionally
  • Results oriented with the ability to be accountable to the achievement of both individual and team goals

 

 

Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 14,000 people and with products available in more than 143 countries, we are one of the world´s leading medical device companies. We are constantly growing our business and always looking for new ways to move forward – we explore, learn and look for new ways of doing things.

 

Visit us on Coloplast.com.

Watch the film. Follow us on LinkedIn. Like us on Facebook.

 

Coloplast is committed to a policy of Equal Employment Opportunity (EEO) which means we employ and promote individuals based on their merits, regardless of race, color, religion, sex, national origin, age, disability, veteran status, pregnancy, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, status with regards to public assistance or any other protected classification.

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