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3M has a long-standing reputation as a company committed to innovation. We provide the freedom to explore and encourage curiosity and creativity. We gain new insight from diverse thinking, and take risks on new ideas.
Here, you can apply your talent in bold ways that matter.Job Description:3M is seeking a Quality Management System (QMS) Analyst for the Health Care Business Group (HCBG) located in Maplewood, MN. Here, you go.Job Summary
The person hired for the position of Quality Management System (QMS) Analyst
will help with the Health Care Business Group (HCBG) QMS documentation program to ensure compliance with external regulations and business-related needs. This person will support ENOVIA (Electronic Document Management System), a globally used document management system, and provide administrative support to users. The QMS Analyst will provide guidance relative to proficient documentation while identifying and implementing continuous improvement practices. This person will work closely with the HCBG team in St. Paul, including various process owners of functions such as Quality, Regulatory, Laboratory, Clinical, Manufacturing, as well as with HCBG divisions and global sites.Primary Responsibilities
include but are not limited to the following:
- Leads projects relative to QMS documentation
- Maintains ENOVIA and provides administrative support to users
- Develops and implements standardized documents in collaboration with QMS process owners, HCBG divisions and global sites
- Drives cross-functional and global collaboration relative to HCBG QMS documents
- Performs technical review of new and revised documents and manages existing documents
- Uses analytical and administrative skills to analyze and evaluate documentation needs, interpret and apply applicable regulations
- Bachelor's degree or higher from an accredited institution
- Experience working in a Documentation, Quality Management System (QMS), Quality and/or Regulatory environment
Location: Maplewood, MN Travel: May include up to 15% domestic/internationalRelocation: Is not authorized
- Bachelor's degree or higher in a Science or related discipline from an accredited institution
- Minimum of one (1) year of combined QMS, Quality and/or Regulatory Affairs experience
- Previous experience working in a Food and Drug Administration (FDA) regulated device, combination, or drug environment or other regulated industry
- Ability to multi-task and prioritize with strong analytical and problem solving skills
- Ability to identify opportunities for improvement and lead change
- Proficient in technical review and writing, communication, and collaboration
- Microsoft Office proficient, experience with administration of ENOVIA or another document management system
Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).
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