Senior Quality Management Systems Analyst (Maplewood, MN)
Maplewood , Minnesota
October 21, 2017
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Job Description:

3M is seeking a Senior Quality Management System (QMS) Analyst for the Healthcare Business Group located in Maplewood, MN. At 3M, you can apply your talent in bold ways that matter. Here, you go.

Job Summary:
The person hired for the position of Senior Quality Management System (QMS) Analyst will help with the development and implementation of the standardized Health Care Business Group (HCBG) QMS documentation program to ensure compliance with external regulations and business-related needs. 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. The Senior QMS Analyst will provide leadership and guidance relative to proficient documentation while identifying and implementing continuous improvement practices. In addition, this person will support ENOVIA (Electronic Document Management System), a globally used document management system, and provide administrative support to users.

Primary Responsibilities include but are not limited to the following:
  • Drives cross-functional and global collaboration relative to HCBG QMS documents
  • Develops and implements standardized documents in collaboration with QMS process owners, HCBG divisions and global sites
  • Performs technical review of new and revised documents and manages existing documents
  • Leads projects relative to QMS documentation
  • Maintains ENOVIA and provides administrative support to users
  • Uses analytical and administrative skills to analyze and evaluate documentation needs, interpret and apply applicable regulations
  • Applies leadership and change management / influencing skills when working with all levels of employees to buy into concepts and to allow them to increase knowledge, learn new skills, adopt new behaviors, and to skillfully negotiate team problems to a win/win resolution
  • Negotiates and counsels an audience which may not be knowledgeable in the subject area to help with change management, thereby demonstrates solid persuasion skills and manages differing interests and perspectives.

Basic Qualifications:
  • Bachelor's degree or higher from an accredited institution
  • Experience working in a Documentation, Quality Management System (QMS), Quality and/or Regulatory environment

Preferred Qualifications:
  • Bachelor's degree or higher in a Science or related discipline from an accredited institution
  • Minimum of two (2) years of 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
  • Strong demonstrated project leadership ability and the ability to lead teams and drive change
  • Ability to multi-task and prioritize with strong analytical and problem solving skills
  • Ability to identify opportunities for improvement and lead change
  • Experience in Lean Six Sigma
  • Proficient in technical review and writing, communication, and collaboration
  • Microsoft Office proficient, experience with administration of ENOVIA or another document management system

Location: Maplewood, MN
Travel: May include up to 15% domestic/international
Relocation: Is not authorized

Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).

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