Senior Quality Engineer (Remote - United States)

Thank you for your interest in joining Solventum. Solventum is a new healthcare company with a long legacy of solving big challenges that improve lives and help healthcare professionals perform at their best. At Solventum, people are at the heart of every innovation we pursue. Guided by empathy, insight, and clinical intelligence, we collaborate with the best minds in healthcare to address our customers’ toughest challenges. While we continue updating the Solventum Careers Page and applicant materials, some documents may still reflect legacy branding. Please note that all listed roles are Solventum positions, and our Privacy Policy: https://www.solventum.com/en-us/home/legal/website-privacy-statement/applicant-privacy/ applies to any personal information you submit. 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 (completed and verified prior to start) AND three (3) years of combined product, quality, engineering, and/or laboratory experience in a private, public, government or military environment
  OR
• High School Diploma/GED AND seven (7) years of combined product, quality, engineering, and/or laboratory experience in a private, public, government or military environment
   

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

• Experience working in an FDA-regulated device, combination product, or pharmaceutical environment
• Experience supporting medical device product quality issue reviews, including design controls, requirements, and test method validation activities
• Experience leading initiatives or teams, including identifying improvement opportunities and driving change across cross-functional stakeholders
• Experience applying statistical and quality engineering tools, such as basic statistics, Gage R&R, Analysis of Variance (ANOVA), Failure Modes and Effects Analysis (FMEA), Statistical Process Control (SPC), process capability analysis, acceptance sampling, correlation and regression, and design of experiments (DOE)
• Experience influencing stakeholders and driving outcomes related to compliance, continuous improvement, product risk mitigation, or manufacturing process capability improvement
• Experience communicating technical or quality-related information, including providing concise, fact-based updates to leadership and cross-functional teams
• Experience applying problem-solving and continuous improvement approaches to prioritize work, manage competing demands, a