| Job Description: Post Market Surveillance Lead Collaborate with Innovative 3Mers Around the World Choosing where to start and grow your career has a major impact on your professional and personal life, so it's equally important you know that the company that you choose to work at, and its leaders, will support and guide you. With a diversity of people, global locations, technologies and products, 3M is a place where you can collaborate with 96,000 other curious, creative 3Mers. "For more than 30 years at 3M, I've seen firsthand how it's a place where curious, creative and collaborative people thrive and build a rewarding career. As a leader in this company, my goal is to ensure each 3Mer sees and feels the positive impact we're making around the world" - Mike Roman, chief executive officer and chairman, 3M This position provides an opportunity to transition from other private, public, government or military environments to a 3M career. The Impact You'll Make in this Role
As a Health Care Business Group Post Market Surveillance (PMS) Lead, 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: - Ensuring compliance with global post market surveillance requirements, including the evaluation of current and new regulations, standards, and guidance impacting Post Market Surveillance systems on an ongoing basis, and implementing solutions to ensure continued regulatory compliance by leading the Global Post Market Surveillance (PMS) process for the Health Care Business Group.
- Managing the end-to-end implementation of post market surveillance process, including procedures, roles & responsibilities, prioritization, deliverables, etc. This also includes maintaining the planning process and master schedule.
- Ensuring appropriate documentation of key data, analysis, and decisions in supporting documents and records
- Developing and delivering post market solutions to support new business / distribution channels / projects
- Acting as a liaison between Post Market Surveillance and other QMS elements (Customer Complaints, Design Assurance, Risk Management, Health Care Compliance & Clinical Research, Divisional Medical Affairs, Affairs, Regulatory, Marketing, Product Quality, Engineering, Service and Repair); Applying Risk Management File and Clinical Evaluation content to Post Market Surveillance processes. Leading project teams to implement solutions to Post Market Surveillance issues and supporting related CAPAs.
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 of Science degree or higher in a STEM or medical discipline (completed and verified prior to start) from an accredited institution
- Five (5) combined years of experience in medical device, pharmaceutical and/or biological industry in a private, public, government or military environment
- Experience in one or more of the following areas: post market surveillance, risk management, product complaint handling, CAPA, product investigations, and Quality Management Systems software
- Experience in managing FDA / Notified Body compliance inspections to one or more of the following standards: Medical Device QSR, Pharmaceutical GMP, EU Medical Device Regulation, ISO 13485, and/or ISO 14971
- Knowledge and use of statistical tools and techniques to determine trends related to reactive and proactive post market data, including use of various techniques to establish statistical thresholds. (e.g. Minitab and/or Excel tools to analyze complaint rates, adverse events, design changes, non-conformances, clinical studies, competitor products, and manufacturing changes)
Additional qualifications that could help you succeed even further in this role include: - Global experience ensuring compliance with post market surveillance requirements
- Experience managing the end-to-end implementation of post market surveillance processes, maintaining the planning process, and master schedule.
- Continuous improvement project experience as a certified Green Belt, Black Belt, or Master Black Belt
- Experience analyzing data from Power BI or other statistical tools.
- Demonstrated success in project management, agile, leading teams, and influencing senior leaders and others to achieve results
Location: Maplewood, MN preferred, and may consider a remote U.S. work location Travel: May include up to 20% domestic and international travel 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 3M offers many programs to help you live your best life - both physically and financially. To ensure competitive pay and benefits, 3M regularly benchmarks with other companies that are comparable in size and scope. Resources for You For more details on what happens before, during and after the interview process, check out the Insights for Candidates page at 3M.com/careers. Learn more about 3M's creative solutions to the world's problems at www.3M.com or on Twitter @3M. Responsibilities of this position include that corporate policies, procedures and security standards are complied with while performing assigned duties. 3M is an equal opportunity employer. 3M will not discriminate against any applicant for employment on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status. Please note: your application may not be considered if you do not provide your education and work history, either by: 1) uploading a resume, or 2) entering the information into the application fields directly. 3M Global Terms of Use and Privacy Statement
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