3M
As a Medical Device Reporting Associate, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. Here, you will make an impact by:
- Electronically process events to determine complaint and reportability status, this includes the collection, compilation, and triage of product quality customer issues
- Complete applicable Medical Device Reports as required per internal policy and government regulations (for example, US Food and Drug Administration)
- Ensure that timely complaint investigations are adequate, accurate, and detailed
- Perform tasks to obtain adequate information to ensure proper documentation and closure of each complaint
- Collaborate with appropriate technical, clinical, field, and/or returned product analysis employees to determine reporting eligibility
- Ensure accurate data entry, scanning, and retention of documents to complete event files
- Support internal systems, methods, and procedures to maintain compliance and apply analytical skills for the analysis and interpretation of complaint trends
- Develop and maintain product knowledge of 3M Medical products
- Provide inspection support for US Food and Drug Administration (FDA) and global regulatory agencies
- Develop and maintain a working knowledge of global regulations and standards related to post-market quality and complaint handling
- Complete assigned projects specific to post-market quality and complaint handling, utilizing project management, process improvement, customer service, and communication skills
Your Skills and Expertise
To set you up for success in this role from day one, 3M requires (at a minimum) the following qualifications:
- Bachelor’s degree or higher (completed and verified prior to start)
- Three (3) years of experience in one or more of the following areas: quality, medical device products in a quality or manufacturing setting, customer service, corporate operations, or supporting cross functional teams in a private, public, government or military environment
- Two (2) years of experience working as a Licensed Health Care Professional
- Two (2) years of Medical Device Product knowledge in the areas of medical respirators, bandages, braces, etc.
- Two (2) years of experience dealing with customer issues which need to comply with U.S. Food and Drug Administration (FDA) regulations and/or Vigilance reporting per EU MDR requirements
Additional qualifications that could help you succeed even further in this role include:
- Previous Medical Device Reporting experience
- Two (2) to five (5) years of experience working in the medical device industry
- Master’s degree or higher
- Experience using customer support software such as SAP, Salesforce / CFR / CIR, BOXI, Microsoft, Power BI, and/or Qlikview
- Experience performing complaint investigations, documenting status updates, and accurate financial credit adjustments.
- Ability to perform analysis that impacts resource utilization, speed, costs, and improvements in a quality area.
- Ability to work in a matrixed and geographically diverse business environment to solve complex customer & 3M problems using innovative solutions.
- Confidence to make sound decisions in the absence of detailed instructions in a manufacturing environment.
- Some knowledge of good documentation practices (GDP), good manufacturing practices (GMP) and quality systems in a regulated environment would also be beneficial.
- Working understanding of the following standards: ISO 9001, 13485, 14971, 22442 62366, and/or TR 24971
Work location:
- Work Your Way Eligible (Employee choice to work remote, on site, or hybrid)
Travel: May include up to 5% domestic/international
Relocation Assistance: May be authorized
Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).
Supporting Your Well-being
| Salary: | A range of 91,279.00 – 111,564.00 USD Annually. Performance bonus structures |
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