3M is seeking a Sr. Quality Engineer for the Critical and Chronic Care Solutions Division (C3SD) located in Maplewood, MN. At 3M, you can apply your talent in bold ways that matter. Here, you go.
The person hired for this opportunity will provide quality engineering leadership and support to high priority new product development programs, marketed products, and continuous improvement and cost reduction programs. C3SD is an exciting growth business within 3M's Health Care portfolio and a market leader in many product categories. C3SD operates in a Food and Drug Administration (FDA) regulated environment with an excellent brand and quality reputation.
The Sr. Quality Engineer will work and interact significantly with 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 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.
Other duties as assigned.
Bachelor’s degree or higher from an accredited institution
Minimum of two (2) years combined experience working in a product, quality, engineering, and/or laboratory/technical function
Bachelor’s degree or higher in Mechanical Engineering, Chemical Engineering, Statistics, Chemistry, Microbiology from an accredited institution
Minimum of four (4) years of combined experience working in a Product, Quality, Engineering, Microbiology and/or Laboratory environment
Previous experience working in an FDA regulated device, combination, or drug 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 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 Lean Manufacturing
Test method development and validation experience
Minitab and Microsoft Office proficient
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 a sponsorship for employment visa status (e.g. H1B status).