Senior Quality Engineer (Remote - United States)

SOLVENTUM•Remote - Minnesota, MN

7d•$106,000 - $145,750•Remote

About The Position

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. 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. 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.

Requirements

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
Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).

Nice To Haves

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, and deliver results

Responsibilities

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
Responsibilities of this position include that corporate policies, procedures and security standards are complied with while performing assigned duties.