Quality Systems Engineer

Solventum-; St. Louis (MO); On-site; USD 90,000 - 110,000; Full time

Job summary

Solventum, a new healthcare company, is seeking a Quality Systems Engineer to join the Medical Surgical Division in Maryland Heights, Missouri. This onsite role focuses on managing the QMS, ensuring regulatory compliance, and supporting audits to improve patient outcomes.

You will lead document control efforts, drive process improvements, and work with cross-functional teams to maintain accuracy and readiness for customer and regulator inspections.

Qualifications

• Bachelor degree and at least 5 years in Quality Management Systems (QMS) or equivalent regulated environment.
• ISO 13485, ISO 9001 experience preferred.
• Technical writing and CAPA experience required.
• ISO 13485 Lead Auditor Certification is a plus.

Responsibilities

• Manage various elements of the QMS to ensure compliance and continuous improvement.
• Ensure compliance to relevant regulations and standards.
• Create and support QMS document control and document change processes.
• Host customer audits and regulator inspections for the site.
• Lead internal audits and drive corrective actions.
• Support reporting and system use/training as needed.
• Process document changes in an efficient and timely manner.
• Ensure accuracy and completeness of documents in the controlled system.
• Ensure document controls in place for technical accuracy and review.
• Follow global and business processes and procedures.
• Interpret regulations and represent the customer to foster a quality culture.

Skills

QMS experience

Technical writing

CAPA writing & coaching

Regulatory interpretation

Education

Bachelor of Science degree

High School Diploma/GED

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: https://www.solventum.com/en-us/home/legal/website-privacy-statement/applicant-privacy/Job Description:Solventum, a new healthcare company with a rich historyWe’re a new company built on a trusted legacy of solving big healthcare challenges that improve patient lives while enabling healthcare professionals to perform at their best. People, and their well-being, are at the heart of every scientific advancement we pursue. We partner closely with the best minds in healthcare — guided by empathy, insight, and clinical intelligence — to solve our customers’ toughest challenges.Our ultimate goal? Move humanity forward by improving health for everyone. Because at Solventum, we never stop solving for you.The impact you’ll make in this roleAs a Quality Systems 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:· Managing various elements of the QMS to ensure compliance and continuous improvement· Ensure compliance to relevant regulations and standards· Create and support QMS document control and document change processes.· Communicate with the manager about compliance issues or if a negative trend is identified· Hosting customer audits and regulator inspections for the site· Leading internal audits· Support reporting and system use/training as needed· Process document changes in an efficient and timely manner· Ensure accuracy and completeness of documents· Ensure documents accessible through the controlled document management system· Ensure document controls in place for technical accuracy and review· Follow global and Business processes and procedures· Interpreting regulations and representing the customer to foster a quality culture and mindset throughout the plant.Your skills and expertiseThese are the core capabilities and experiences essential to make an impact:Required Qualifications:Bachelor of Science degree (completed and verified prior to start) from an accredited institution AND 5 years of experience in Quality Management Systems (QMS) or equivalent regulated environment.ORHigh School Diploma/GED from AND 8 years of Quality Management Systems (QMS) experienceNice to Have” Qualifications:· ISO 13485, ISO 9001, and/or pharmaceutical audit and inspection experience· ISO 13485 Lead Auditor Certification· Technical writing skills· CAPA writing and coaching experienceWork Location: Onsite: Maryland Heights, Missouri LocationTravel: May include up to 10% travel within sales territoryRelocation Assistance: May be authorizedPay TransparencyApplicable to US Applicants Only: The base salary range for this position is $90,000.00 to $110,000.00 with additional bonus opportunities based on performance. 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-RewardsLegal & ComplianceMust be legally authorized to work in the country of employment without sponsorship for employment visa status.Where this role fitsThis role sits within Solventum’s Medical Surgical Divisi on, supporting the Acera product portfolio and its clinically proven solutions designed to improve patient outcomes and surgical efficiency. Through Acera Surgical and the Restrata product, the team advances evidence‑based wound care technologies that support healing across multiple surgical specialties, helping frontline healthcare providers deliver safer, more effective care.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.Solventum Global Terms of Use and Privacy StatementCarefully 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.Please access the linked document by clicking here . Before submitting your application you will be asked to confirm your agreement with theterms.