Senior Quality Engineer (Remote - United States)

About the role

Solventum is a new healthcare company dedicated to improving lives through innovative solutions. We partner with healthcare professionals to develop breakthrough medical devices that enhance patient care and professional performance.

Responsibilities

• Provide 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.
• Lead investigations for nonconforming materials, complaints, and supplier issues.
• Assure compliance to internal Standard Operating Procedures (SOPs) and external regulations.
• Lead Corrective and Preventive Action (CAPA), Risk Management including Post Market Surveillance product support, Risk Reviews, and Material Review Boards.
• Represent the customer, evaluate customer complaints and issues, samples and trends, and determine the necessary action plans.
• Interact with other Solventum facilities and outside suppliers to ensure product quality and performance.
• Other duties as assigned.

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.

Qualifications

• 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.

Skills

• Curiosity and collaboration with innovative and diverse colleagues.
• Technical expertise in quality assurance engineering.
• Leadership in investigations and corrective actions.
• Statistical and quality engineering tools proficiency.
• Stakeholder influence and continuous improvement mindset.
• Effective communication and problem-solving abilities.

Benefits

Supporting Your Well-being
Solventum offers various programs to enhance your physical and financial well-being. Competitive pay and benefits are determined based on market benchmarks and individual qualifications. For more details, visit Total Rewards.

Pay

$106,000 - $145,750
This range includes base pay plus variable incentive pay, if eligible.

Schedule

Remote in United States (preferred with ability to commute to Eagan, MN or a US manufacturing plant location as needed)

Travel

May include up to 10% domestic/international travel

Relocation Assistance

May be authorized

Legal Compliance

Corporate policies, procedures, and security standards must be complied with while performing assigned duties.

Equal Opportunity Employer

Solventum is committed to maintaining the highest standards of integrity and professionalism in its recruitment process. It does not discriminate against any applicant for employment on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status.