Quality Systems Engineer

USA SOLVENTUM US LLC; St. Louis (MO); On-site; USD 90,000 - 110,000; Full time

Benefits offered by this job

Medical

Dental & Vision

Health Savings Accounts

Health Care & Dependent Care Flexible

Disability Benefits

Life Insurance

Voluntary Benefits

Paid Absences and Retirement Benefits

etc.

Job summary

Solventum is seeking a Quality Systems Engineer in Maryland Heights, MO to manage the QMS, ensure regulatory compliance, and support document control. You will host audits, lead internal audits, and drive CAPA processes to improve product quality and patient safety.

The role requires a BS in a science field with 5 years of QMS/regulatory experience or an HS diploma with 8 years. ISO 13485/9001 exposure and strong technical writing are a plus.

Qualifications

• BS in Science or equivalent accredited degree with 5 years in QMS or regulated environments.
• HS Diploma/GED with 8 years of QMS experience.
• ISO 13485, ISO 9001 familiarity and/or pharmaceutical audit/inspection experience a plus.
• Technical writing and CAPA experience are desirable.

Responsibilities

• Manage various elements of the QMS to ensure compliance and continuous improvement.
• Ensure compliance with relevant regulations and standards.
• Create and support QMS document control and change processes.
• Communicate with management about compliance issues or negative trends.
• Host customer audits and regulator inspections for the site.
• Lead internal audits and support reporting and system use/training as needed.
• Oversee document changes efficiently and ensure accessibility in the controlled system.
• Interpret regulations and represent the customer to foster a quality culture across the plant.

Skills

QMS Experience

Regulatory Compliance

Internal Audits

Document Control

CAPA writing

Technical Writing

Audit Coordination

Education

BS in Science (accredited)

HS Diploma/GED with 8 years QMS experience

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 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. 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 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.
• 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

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.).

• 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

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 Division, 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.

Fraud Prevention

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.

Equal Opportunity Employer

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.

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 here. Before submitting your application you will be asked to confirm your agreement with the terms.

About Solventum

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.