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Here, you can apply your talent in bold ways that matter.Job Description:3M is seeking a Quality Compliance Auditor for the Health Care 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 Quality Compliance Auditor
will schedule, conduct, and issue reports for comprehensive audits of drug and medical device product quality systems using Food and Drug Administration (FDA) and related industry standards as well as current industry practices. These audits will address compliance, suitability, and effectiveness of both the system as well as some technical aspects of the associated products.
The position will require occasional international travel to both 3M and non-3M locations. Other requirements of this position may include periodically conducting training as well as participation in projects. Primary Responsibilities
include but are not limited to the following:
- Schedule, conduct, and report results of Quality Management System (QMS) audits.
- Communicate summary of audit results to management team.
- Lead short-term audit teams.
- Bachelor's degree or higher in an Engineering or Science discipline from an accredited institution
- Minimum of three (3) years of combined experience in Quality and/or Manufacturing in a health care regulated industry
- Minimum of one (1) year experience performing audits of quality management systems
- Recent experience with auditing quality management systems of either device or drug development or manufacturing organizations
- Professional certification(s): American Society for Quality (ASQ,: Biomedical Auditor (CBA) or Quality Auditor (CQA) and/or Exemplar Global Incorporate (formerly known as RABQSA) Quality Management (ISO 9001)
- Prior experience in auditing to Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and/or software design requirements
- Willingness and ability to travel frequently, may require several trips per month of differing durations
- Excellent verbal and written communication skills (extensive report writing is expected)
- Bi-lingual, English and Spanish or Chinese Mandarin
- Self-starter/self-directed that leads with high energy and passion
- Ability to work with all levels in an organization and across disciplines
- Ability to multi-task and handle large workloads under time constraints
- Microsoft Office proficient, SAP experience a plus
Location: Maplewood, MN
Travel: May include up to 30% 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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