Quality Systems Engineer

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

Benefits offered by this job

Medical, Dental & Vision

Retirement Benefits

Paid Absences

Job summary

Solventum Corporation in Maryland Heights, Missouri, is seeking a Quality Systems Engineer to manage the QMS, ensure regulatory compliance, and support audits. You will lead document control, drive continuous improvement, and coordinate with cross-functional teams on quality initiatives.

The role requires a BS with 5 years in QMS (or 8 years with HS), ISO 13485/9001 familiarity, and strong technical writing. Onsite, travel up to 10%, base $90k–$110k with bonus and benefits.

Qualifications

• BS degree and 5 years of QMS or equivalent in regulated settings.
• Or HS diploma with 8 years of QMS experience.
• ISO 13485/9001 knowledge and audit exposure are preferred.

Responsibilities

• Manage elements of the QMS to ensure compliance and continuous improvement.
• Ensure regulatory compliance and support audits and inspections.
• Create and support QMS document control and change processes.
• Lead internal audits and host customer/regulator inspections.
• Support reporting and system use/training as needed.

Skills

Quality Management Systems

Regulated environments

ISO 13485/9001 familiarity

CAPA writing and coaching

Education

Bachelor of Science degree

High School Diploma/GED

Tools

Technical writing

Job description

Quality Systems Engineer page is loaded## Quality Systems Engineerremote type: On-sitelocations: US, Missouri, St. Louistime type: Full timeposted on: Posted 30+ Days Agojob requisition id: R01133962At 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 history**We'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.**The impact you'll make in this role**As 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 expertise**These 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.* OR* High School Diploma/GED from AND 8 years of Quality Management Systems (QMS) experience**Nice 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 experience**Work Location:** Onsite: Maryland Heights, Missouri Location**Travel:** May include up to 10% travel within sales territory**Relocation Assistance:** May be authorized**Pay Transparency**Applicable 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:**Legal & Compliance**Must be legally authorized to work in the country of employment without sponsorship for employment visa status.**Where this role fits**This 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 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.Please access the linked document by clicking. Before submitting your application you will be asked to confirm your agreement with theterms.