Quality Engineer (Onsite - Brookings, SD)

USA SOLVENTUM US LLC; Brookings (SD); On-site; USD 85,000 - 117,000; Full time

Job summary

Solventum is seeking a Quality Engineer to support product assurance for commercialized products in a regulated environment. You will partner with manufacturing and quality teams to drive improvement across design control, change management, and QC testing.

The role requires a relevant science/engineering degree and QA experience, including audits, root cause analysis, and data-driven problem solving. Onsite at Brookings, SD with travel up to 5%.

Qualifications

• Bachelor’s degree or higher in science/engineering/math and 1 year quality manufacturing or quality lab experience, or equivalent.
• Experience applying quality system requirements, audits, metrology, calibration, and supplier management.
• Experience with root cause analysis and data analysis techniques.

Responsibilities

• Provide product assurance engineering support for commercialized products, including design control and change management.
• Participate in customer and internal audits to identify improvements.
• Ensure QA for products in FDA-regulated environments, including material control and DH records.
• Collaborate with manufacturing engineers to resolve quality issues.
• Lead investigations, corrective actions, and monitoring of nonconforming materials.

Skills

Quality assurance

Auditing

Problem solving

Data analysis

Communication

Team collaboration

Lean Six Sigma

Education

Bachelor’s degree in science/engineering/math

High School Diploma + 5 years quality experience

Tools

Microsoft Office (Word, Excel, PowerPoint, Access)

Statistical tools (SPC, DOE, FMEA)

Quality management systems (ISO 13485, 21 CFR 210/211/820)

Job description

At Solventum, we improve lives by helping healthcare professionals do their best work. Join a team using innovation and insight to make a real impact on the future of healthcare. All roles listed are with Solventum, and we’re committed to protecting your personal information—learn more in our Privacy Policy

Job Description: Quality Engineer (Solventum)

3M Health Care is now Solventum

At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers’ toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the better while enabling healthcare professionals to perform at their best. Because people, and their wellbeing, are at the heart of every scientific advancement we pursue. We partner closely with the brightest minds in healthcare to ensure that every solution we create melds the latest technology with compassion and empathy. Because at Solventum, we never stop solving for you.

Impact You’ll Make in this Role

• 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

• 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
• Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).

Supporting Your Well-being

Solventum offers many programs to help you live your best life – both physically and financially. To ensure competitive pay and benefits, Solventum regularly benchmarks with other companies that are comparable in size and scope. Applicable to US Applicants Only:The expected compensation range for this position is $85,200 - $117,150, which includes base pay plus variable incentive pay, if eligible. This range represents a good faith estimate for this position. The specific compensation offered to a candidate may vary based on factors including, but not limited to, the candidate’s relevant knowledge, training, skills, work location, and/or experience. In addition, this position may be eligible for a range of benefits (e.g., Medical, Dental & Vision, Health Savings Accounts, Health Care & Dependent Care Flexible Spending Accounts, Disability Benefits, Life Insurance, Voluntary Benefits, Paid Absences and Retirement Benefits, etc.). Additional information is available at: https://www.solventum.com/en-us/home/our-company/careers/#Total-Rewards

Responsibilities of this position include that corporate policies, procedures and security standards are complied with while performing assigned duties.

Solventum is committed to maintaining the highest standards of integrity and professionalism in our recruitment process. Applicants must remain alert to fraudulent job postings and recruitment schemes that falsely claim to represent Solventum and seek to exploit job seekers. Please note that all email communications from Solventum regarding job opportunities with the company will be from an email with a domain of @solventum.com. Be wary of unsolicited emails or messages regarding Solventum job opportunities from emails with other email domains. Solventum is an equal opportunity employer. Solventum will 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.

Solventum Global Terms of Use and Privacy Statement Carefully read these Terms of Use before using this website. Your access to and use of this website and application for a job at Solventum are conditioned on your acceptance and compliance with these terms.

Company Overview

A new healthcare company with a rich history. With more than 70 years of delivering healthcare innovations, we continue to move the industry forward by helping to solve our customers’ biggest challenges. 20,000+ employees worldwide. Solventum relies on the courage and the boundless insights of professionals worldwide to achieve exceptional results for our customers and those who rely on them. Healthcare that leads with heart and humility starts with listening and never finishes, only evolves. As long as healthcare challenges remain unsolved, we will be here, united by empathy and a relentless belief that countless lives are improved through our work. Operations in 38 countries. Driven by our dedication to improved outcomes for all we serve, we break through by making unprecedented connections that impact lives. In more than 300 offices and facilities around the world, we work closely with customers and partners to create positive healthcare outcomes that transcend borders. To realize our shared vision, we harness diverse talents and perspectives from every background to not only address our customers' most urgent priorities but anticipate the needs of the future.