Quality Engineer (Onsite - Columbia, MO)

Solventum
US, Missouri, Columbia

Engineering
Full-time
Quality Engineer
ISO 13485
FDA Compliance

Our job summary

The Quality Engineer at Solventum is responsible for ensuring product quality and compliance with regulatory standards such as ISO 9001, ISO 13485, and FDA requirements. The role involves product assurance, audits, validation of equipment and processes, root cause analysis, and continuous improvement activities using statistical and engineering tools. This position supports manufacturing and supplier quality, driving quality improvements through Lean Six Sigma and other best practices.

Thank you for your interest in joining Solventum. Solventum is a new healthcare company with a long legacy of solving big challenges that improve lives and help healthcare professionals perform at their best. At Solventum, people are at the heart of every innovation we pursue. Guided by empathy, insight, and clinical intelligence, we collaborate with the best minds in healthcare to address our customers’ toughest challenges. While we continue updating the Solventum Careers Page and applicant materials, some documents may still reflect legacy branding. Please note that all listed roles are Solventum positions, and our Privacy Policy: https://www.solventum.com/en-us/home/legal/website-privacy-statement/applicant-privacy/ applies to any personal information you submit. As it was with 3M, at Solventum all qualified applicants will receive consideration for employment without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Job Description:

Quality Engineer (Solventum)

We are pleased to report that Solventum has successfully completed the sale of its Purification & Filtration (P&F) business to Thermo Fisher Scientific Inc. (Thermo Fischer). This is a significant milestone for the P&F business, allowing for the strategic investment and resources needed to sustain growth and deliver customer solutions. Please note that this position is scheduled to transfer to a local subsidiary of Thermo Fisher in your country. However, the position is in a country where the transfer of employees to Thermo Fisher is delayed until a later date. By joining Solventum during this transitional period, you will be able to work alongside an energized and mission-driven team who is experiencing this transition along with you. Until the transfer is complete, you will be employed by Solventum, and your employment is subject to all applicable terms and conditions as outlined in our employment agreement and company policies

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.
Reviewing and approving IQ/OQ/PQ documents and validation documents to qualify and validate new equipment and processes.
Participating in and leading customer audits, ISO 9001 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 Division 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 (completed and verified) from an accredited institution

Additional qualifications that could help you succeed even further in this role include:

Bachelor’s degree or higher in Manufacturing/Industrial Engineering, Chemical Engineering, Mechanical Engineering, Statistics/Mathematics from an accredited institution
Three (3) years of engineering experience in a private, public, government or military environment
Experience with quality systems such as Quality Manuals, ISO-13485, 21 CFR Part 210, 211 and 820, metrology, calibration, auditing and supplier management
Working knowledge of root cause analysis tools and techniques
American Society for Quality, Certified Quality Engineer (CQE) certification or willingness to obtain
Proficiency in the use of statistical and quality engineering tools such as exploratory data analysis, basic statistics, Gage R&R, Analysis of Variance, Failure Modes and Effects Analysis, Statistical Process Control and Capability, acceptance sampling, correlation and regression, and experimental design
Excellent verbal and written communication skills
Proficient in MS Office (Word, Excel, PowerPoint, Access) and writing/using data queries, extracts and analysis
Skills including organization, resilience, collaboration, and curiosity.

Work location:

Onsite: Columbia, MO

Travel: May include up to 5% domestic travel

Relocation Assistance: is not 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 $95,825 - $117,120, 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.

Please note: your application may not be considered if you do not provide your education and work history, either by: 1) uploading a resume, or 2) entering the information into the application fields directly.

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