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Principal Configuration Management Specialist

Location: 

Minneapolis, US

Job Family:  Quality Assurance
Country/Region:  United States

Principal Configuration Management Specialist 

Coloplast has an exciting opportunity for a Principal Configuration Management Specialist to join our growing team!

 

The Principal Configuration Management Specialist is responsible for supporting the management of product and business process change control, including performing tasks that drive the timely release and change of product documentation and data throughout the product’s lifecycle.  This position is responsible for supporting facilitation and maintenance of quality master data related to products and contributing to data integrity and compliance.  This position will ensure accurate record retention of Quality System documents in accordance with defined requirements and procedures. This position ensures timely completion of configuration management project outcomes and develops solutions to a variety of complex problems.
 

Major Areas of Accountability

  • Subject matter expert in change control system and related processes
  • Executes training and education of Change Control system users
  • Proficient in applying knowledge of regulations and standards to the creation and management of production documentation, as required
  • Analyzes complex issues and significantly improves, changes, or adapts existing methods including root-cause analysis methodologies
  • Consistently applies good documentation practices
  • Responsible for improving the change request process flow
  • Responsible for executing activities after change request input, including work instruction, travelers, and specifications
  • Proficient in the analysis of configuration management related business processes, systems, and data including requirements and impacts in research, product development, planning, manufacturing, purchasing, product release, product holds, and obsolescence management
  • Contributes to development of local instructions for Change Control in QMS, as required
  • Contributes to the development and reporting of applicable metrics
  • Manages cross-functional projects, as applicable
  • Other tasks as assigned

 

Basic Qualifications

  • Bachelor's degree in a technical field from four-year college or university, or 7-10 years equivalent experience

 

Required Knowledge, Skills, and Abilities

  • Proficient in oral and written communication skills
  • Ability to communicate effectively at all levels, including facilitation of cross-functional meetings
  • Attention to details within the job responsibilities
  • Highly knowledgeable of the principles and best practices of configuration management
  • Knowledgeable of internal records management processes
  • Knowledgeable of related external regulations and standards, including ISO 13485 & 21 CFR 820 requirements
  • Experience supporting both internal and external audits

 

Environmental, Health and Safety Responsibilities

This position will support Coloplast Manufacturing EHS Goals and Objectives:

  • Enforce all company Environment, Health, and Safety policies
  • Ensure employees are properly trained
  • Provide detailed instructions for job performance and explain hazards and safety precautions in assigning employees to a task
  • Plan the work to be certain that employees, material, and equipment are available to perform task safely.
  • Promptly report all incidents in area(s) of responsibility
  • Conduct effective accident investigations immediately after they occur and implement effective corrective actions to ensure that the accident does not reoccur
  • Ensure injured employees receive proper first aid and/or medical treatment
  • Follow-up on all safety related deficiencies to ensure corrective action has been completed
  • Actively support and promote Environment, Health, and Safety activities within the organization

 

Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 12,000 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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Nearest Major Market: Minneapolis

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