Quality Engineer (Onsite - Brookings, SD)
Solventum
Summary
As a Quality 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. Here, you will make an impact by:
Job description
The Impact You'll Make in this Role
As a Quality 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. Here, you will make an impact by:
- Providing product assurance engineering support for commercialized products including specification and design control, change management, risk management, investigations, and continuous improvement.
- Participating in customer audits, ISO 13485 audits, internal audits, and other activities to identify improvement opportunities.
- Providing quality assurance and control for products used in FDA regulated industries, including control of incoming materials, review of in-process tests and release tests and device history records.
- Working with manufacturing engineers and other personnel to solve product quality issues.
- Leading investigations, corrective action responses, trending and monitoring for nonconforming materials, complaints, and supplier issues.
- Interacting with business quality personnel and outside suppliers to ensure product quality and performance.
- Driving quality improvement using engineering best practice, statistical techniques, and Lean Six Sigma methodologies.
Your Skills and Expertise
To set you up for success in this role from day one, Solventum requires (at a minimum) the following qualifications:
- Bachelor's degree or higher in a science, technology, engineering, or mathematics discipline (completed and verified prior to start) and (1) one year of quality manufacturing or quality laboratory experience in a private, public, government or military environment OR High School Diploma/GED AND five (5) years of quality manufacturing or quality laboratory experience in a private, public, government or military environment
Additional qualifications that could help you succeed even further in this role include:
- Experience applying quality system requirements, including Quality Manuals, ISO 13485, 21 CFR Parts 210, 211, and/or 820, metrology, calibration, auditing, and supplier management.
- Experience applying root cause analysis tools and techniques.
- American Society for Quality (ASQ) Certified Quality Engineer (CQE) certification or willingness to obtain certification.
- Experience applying statistical and quality engineering tools, such as exploratory data analysis, 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 communicating technical or quality-related information through verbal discussions, presentations, and written communications.
- Experience using Microsoft Office applications, including Word, Excel, PowerPoint, and Access, as well as creating and using data queries, extracts, and analyses.
- Experience managing multiple priorities and collaborating with cross-functional teams to support quality, engineering, or operational activities.
Work location: Onsite: Brookings, SD. Travel: May include up to 5% domestic/international travel. Relocation Assistance: May be authorized.
Requirements
- Bachelor's degree or higher in a science, technology, engineering, or mathematics discipline (completed and verified prior to start) and 1 year of quality manufacturing or quality laboratory experience in a private, public, government or military environment OR High School Diploma/GED AND 5 years of quality manufacturing or quality 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)
- Experience applying quality system requirements, including Quality Manuals, ISO 13485, 21 CFR Parts 210, 211, and/or 820, metrology, calibration, auditing, and supplier management
- Experience applying root cause analysis tools and techniques
- American Society for Quality (ASQ) Certified Quality Engineer (CQE) certification or willingness to obtain certification
- Experience applying statistical and quality engineering tools, such as exploratory data analysis, 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 communicating technical or quality-related information through verbal discussions, presentations, and written communications
- Experience using Microsoft Office applications, including Word, Excel, PowerPoint, and Access, as well as creating and using data queries, extracts, and analyses
- Experience managing multiple priorities and collaborating with cross-functional teams to support quality, engineering, or operational activities
Benefits
- Medical, Dental & Vision
- Health Savings Accounts
- Health Care & Dependent Care FSAs
- Disability Benefits
- Life Insurance
- Voluntary Benefits
- Paid Absences
- Retirement Benefits
Company overview
Solventum Corporation is an American healthcare company that was spun off from 3M on April 1, 2024, as an independent publicly traded entity listed on the NYSE under the ticker SOLV. The company represents the healthcare division of the former 3M conglomerate, focusing on advanced medical solutions across several key therapeutic areas. Solventum operates in wound care, oral care, health informatics, and biopharmaceutical filtration markets, with a portfolio that includes well-known brands such as Tegaderm, Nexcare, and other medical device products. With approximately 22,000 employees and headquarters in Maplewood, Minnesota, the company generated $8.25 billion in revenue in 2024. Solventum's mission centers on enabling better, smarter, and safer healthcare through innovative solutions at the intersection of health, materials, and data science. The company continues to expand its portfolio through strategic acquisitions, such as the recent agreement to acquire Acera Surgical for $725 million to enhance its regenerative wound care capabilities.