Senior Quality Engineer

Solventum

Senior Quality Engineer supporting quality assurance for marketed medical devices at Solventum, leading investigations and ensuring compliance. Collaborating with diverse teams to drive improvement in product quality.

Posted 6/25/2026full-timeRemote • Minnesota • 🇺🇸 United StatesSenior💰 $106,000 - $145,750 per yearWebsite

About the role

Key responsibilities & impact

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.

Requirements

What you’ll need

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
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

Benefits

Comp & perks

Medical, Dental & Vision
Health Savings Accounts
Health Care & Dependent Care Flexible Spending Accounts
Disability Benefits
Life Insurance
Voluntary Benefits
Paid Absences
Retirement Benefits

ATS Keywords

✓ Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

quality assurance engineeringtest method validationrisk managementCorrective and Preventive Action (CAPA)Failure Modes and Effects Analysis (FMEA)Statistical Process Control (SPC)design of experiments (DOE)Gage R&RAnalysis of Variance (ANOVA)process capability analysis

Soft Skills

leadershipproblem-solvingcommunicationstakeholder influencecross-functional collaborationcontinuous improvementcustomer evaluationinvestigationchange managementprioritization

Certifications

Bachelor’s degreeHigh School Diploma/GED