Senior Quality Engineer

Jobtailor; Minnesota; Hybrid; USD 85,000 - 105,000; Full time

Job summary

Solventum is seeking a quality assurance engineer to support marketed medical device products, including handling complaints, stability studies, and validation activities. You will lead investigations into nonconformances and supplier issues while driving CAPA and risk management.

Collaboration across cross-functional teams and adherence to SOPs and regulatory requirements are essential. You will interact with multiple facilities to ensure ongoing product quality and effectiveness, applying

Qualifications

• Bachelor’s degree (or higher) with 3+ years of related product/quality/engineering/lab experience OR HS diploma with 7+ years of related experience.
• Experience in FDA-regulated device, combination product, or pharmaceutical environments.
• Experience supporting medical device quality issue reviews, including design controls and test method validation.
• Experience leading initiatives or teams, including identifying improvement opportunities and driving cross-functional change.
• Experience applying statistical and quality engineering tools (e.g., basic statistics, Gage R&R, ANOVA, FMEA, SPC, DOE).
• Experience influencing stakeholders to drive compliance, continuous improvement, or process capability improvements.
• Strong communication of technical or quality information to leadership and cross-functional teams.
• Ability to prioritize, manage competing demands, and deliver results.

Responsibilities

• Provide QA engineering support for marketed medical device products (complaints, stability studies, method validations, investigations, risk management, CAPA, and continuous improvement).
• Lead investigations for nonconforming materials, complaints, and supplier issues.
• Ensure compliance with SOPs and external regulations.
• Lead CAPA and risk management activities including post-market surveillance and MRB."
• Represent the customer in evaluating complaints and trends and determine action plans.
• Coordinate with Solventum facilities and outside suppliers to ensure product quality.

Skills

quality assurance engineering

test method validation

risk management

CAPA

FMEA

SPC

DOE

Gage R&R

ANOVA

process capability analysis

Education

Bachelor’s degree

High School Diploma/GED

Job description

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.

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
• 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

Hard Skills

• 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

Soft Skills

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

Certifications & Qualifications

• Bachelor’s degree
• High School Diploma/GED