Senior Quality Engineer

3M is science applied to life. At 3M, we are in your cell phone. We are in your car. We are at your doctor’s office. You are never more than 10 feet from a 3M product. 3M helps make it possible for many other companies to do what they do.

The person hired for the position of Sr. Quality Engineer will provide Quality engineering leadership and support to 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 Senior 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.

* Responsible 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. * Quality leader and core team member on New Product Introduction (NPI) projects. * 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.

**Basic Qualifications:** * Bachelor's degree or higher from an accredited university * Minimum of two (2) years combined experience working in a product, quality, engineering, microbiology and/or laboratory/technical function **Preferred Qualifications:** * Bachelor’s degree or higher in Mechanical Engineering, Chemical Engineering, Statistics, Chemistry, Microbiology or related discipline from an accredited university * Minimum of four (4) years combined experience working in a Product, Quality, Engineering, Microbiology and/or Laboratory/Technical function * Previous experience working in an FDA regulated device, combination, or drug environment * Strong demonstrated leadership ability and the ability to 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 and prioritize * Strong analytical and problem solving skills * 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 * Ability to identify opportunities for improvement and lead change * Minitab and Microsoft Office proficient