Sr. Quality Assurance Engineer

Thank you for your interest in working for our Company. Recruiting the right talent is crucial to our goals. On April 1, 2024, 3M Healthcare underwent a corporate spin-off leading to the creation of a new company named Solventum. We are still in the process of updating our Careers Page and applicant documents, which currently have 3M branding. Please bear with us. In the interim, our Privacy Policy here: https://www.solventum.com/en-us/home/legal/website-privacy-statement/applicant-privacy/ continues to apply to any personal information you submit, and the 3M-branded positions listed on our Careers Page are for Solventum positions. As it was with 3M, at Solventum all qualified applicants will receive consideration for employment without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Job Description:

Senior Quality Engineer (Solventum)

3M Health Care is now Solventum

At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers’ toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the better while enabling healthcare professionals to perform at their best. Because people, and their wellbeing, are at the heart of every scientific advancement we pursue.

We partner closely with the brightest minds in healthcare to ensure that every solution we create melds the latest technology with compassion and empathy. Because at Solventum, we never stop solving for you.

The Impact You’ll Make in this Role
As a Senior Quality Assurance Engineer, 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:

• Providing quality assurance engineering support for marketed medical device products including customer complaints, stability studies, test method validations, investigations, risk management, change management and continuous improvement. 
• Leading investigations for nonconforming materials, complaints, and supplier issues.
• Assuring compliance to internal Standard Operating Procedures (SOP's) and external regulations. Leading Corrective and Preventive Action (CAPA), Risk Management including Post Market Surveillance product support, Risk Reviews, and Material Review Boards.
• Representing the customer, evaluating customer complaints and issues, samples and trends, and determining the necessary action plans.
• Interacting with other Solventum facilities and outside suppliers to ensure product quality and performance.
• Other duties as assigned

Your Skills and Expertise 

To set you up for success in this role from day one, Solventum requires (at a minimum) the following qualifications:

• Bachelor’s degree or higher AND three (3) years of experience in combined product, quality, engineering, and/or laboratory/technical experience in a private, public, government or military environment

OR

• High School Diploma/GED from AND ten (10) years of experience in combined product, quality, engineering, and/or laboratory/technical experience in a private, public, government or military environment

Additional qualifications that could help you succeed even further in this role include:

• 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
• Demonstrated proficiency in the use of statistical and quality engineering tools such as basic statistics, Gage R&R, Analysis of Variance, Failure Modes and Effects Analysis, Statistical Process Control and Capability, acceptance sampling, correlation and regression, and experimental design.
• Demonstrated successful organizational influence in areas including, but not limited to, compliance excellence, continuous improvement, product-related risk mitigation, and/or manufacturing process capability improvement.
• Strong verbal and written communication skills with the ability to provide diligent, concise, and fact-based communication to Executive Management, and cross-functional peers
• Strong decision-making, problem-solving, and continuous improvement skills with the demonstrated ability to create momentum and deliver results in a timely manner by prioritizing personal workloads

Work location: Hybrid - (Maplewood, MN or Brookings, SD)