3M is seeking a Senior Quality Engineer for the Medical Solutions Division (MSD) located in Maplewood, MN. At 3M, you can apply your talent in bold ways that matter. Here, you go.
The person hired for the position of Senior Quality Engineer will provide quality engineering leadership and support to new product development programs, marketed products, and continuous improvement and cost reduction programs. MSD is an exciting growth business within 3M's Health Care portfolio and a market leader in many product categories. MSD operates in a Food and Drug Administration (FDA) and International Organization for Standardization (ISO) 13485 regulated environment with an excellent brand and quality reputation.
The Senior Quality Engineer will work within the Medical Materials and Technologies business and interact significantly with key customers and other cross functional team members (lab, plant manufacturing, manufacturing technology, regulatory, clinical, etc.). This position can provide a great opportunity to learn, grow, and develop as an employee.
Primary Responsibilities include but are not limited to the following:
Quality leader and core team member on New Product Introduction (NPI) projects.
Responsibility for Quality Assurance (QA) support of marketed products. Support activities include change management, customer complaints, risk management, quality improvement and cost reduction projects, and compliance activities.
Leader or team member of quality improvement projects to reduce costs and reduce customer complaints.
Assessing and validating test methods and performing cross-over studies.
Developing and analyzing shelf life and stability studies to set and validate our product claims.
Assuring compliance to internal Standard Operating Procedures (SOP's) and external regulations. Leading Corrective and Preventive Action (CAPA), Risk Management, Risk Reviews, Material Review Boards, and change control.
Representing and communicating with the customer, evaluating customer complaints and issues, samples and trends, and determining the necessary action plans.
Interacting with and supporting our plant manufacturing locations (traveling to plant sites as necessary).
Helping to drive and foster a quality environment and mindset throughout the business.
For additional information, please visit: www.3m.com/medical
This position provides an opportunity to transition from other private, public, government or military environments to a 3M career.
Bachelor’s degree or higher (completed and verified prior to start) from an accredited institution
Minimum of five (5) years combined experience working in a product, quality, engineering and/or laboratory/technical function in a private, public, government or military environment
Bachelor’s degree or higher in a Science, Technology, Engineering, Mathematics (STEM) or related discipline from an accredited institution
Minimum of seven (7) years combined experience working in a product, quality, engineering and/or laboratory/technical function in a private, public, government or military environment
Strong interpersonal skills and ability to successfully interact with key customers
Previous experience working in a regulated environment
Strong demonstrated leadership ability and the ability to identify opportunities for improvement and lead teams, drive change, and get things done
Previous experience leading Quality Assurance (QA) efforts for marketed products and new product introduction teams
Previous manufacturing plant experience
Ability to multi-task, prioritize and problem solve
Statistical knowledge and practice Gage Repeatability and Reproducibility (R&R) studies, Statistical Process Control (SPC) and Process Capability, Sampling Plans, Design of Experiments (DOE), Analysis of Variance (ANOVA) and Regression, Process and Product Understanding (PPU) and/or Lean Manufacturing
Test method development and validation experience
Microsoft Office proficient, Minitab a plus
Location: Maplewood, MN
Travel: May include up to 10% 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).
Internal Number: R00942748
At 3M, we apply science in collaborative ways to improve lives daily. With $30 billion in sales, our 90,000 employees connect with customers all around the world.
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.
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