Senior Quality Systems Engineer

Boston ScientificArden Hills, MN
12h

About The Position

Your responsibilities will include: Support Global CE CAPA and NCEP activities as a SME, owner, project manager and/or trainer Responsible for ensuring timely implementation of projects within the GCE Quality Assurance organization, including continuous improvement projects Apply sound, systematic problem-solving methodologies to ensure robust solutions that resolve quality issues Contribute actively to internal BSC global Communities of Practice

Requirements

  • Bachelor's degree in relevant field and 5+ years CAPA/NCEP or equivalent experience
  • Minimum of 5 years of related work experience, preferably in the medical device industry, or an equivalent combination of education and work experience
  • Technical aptitude and demonstrated problem solving skills in the CAPA process
  • Previous CAPA ownership
  • Can use, teach and improve standardized tools
  • Ability to influence the effectiveness of each phase of the CAPA project indirectly lead, including in challenging situations
  • Strong verbal and written communication, and organizational skills
  • Strong networking skills to foster collaborative relationships
  • Ability to communicate effectively with all levels of the organization
  • Must be proactive and able to work independently with minimal supervision; strong collaboration skills are essential
  • Ability to understand procedural documents and evaluate documents to ensure compliance to all applicable regulations and requirements

Responsibilities

  • Support Global CE CAPA and NCEP activities as a SME, owner, project manager and/or trainer
  • Responsible for ensuring timely implementation of projects within the GCE Quality Assurance organization, including continuous improvement projects
  • Apply sound, systematic problem-solving methodologies to ensure robust solutions that resolve quality issues
  • Contribute actively to internal BSC global Communities of Practice
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