Senior Quality Engineer

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.

• 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

• quality assurance engineering
• test method validation
• risk management
• Corrective and Preventive Action (CAPA)
• Failure Modes and Effects Analysis (FMEA)
• Statistical Process Control (SPC)
• design of experiments (DOE)
• Gage R&R
• Analysis of Variance (ANOVA)
• process capability analysis

• leadership
• problem-solving
• communication
• stakeholder influence
• cross-functional collaboration
• continuous improvement
• customer evaluation
• investigation
• change management
• prioritization

• Bachelor’s degree
• High School Diploma/GED