Quality Systems Engineer

Location: St. Louis

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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.

ORHigh 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 $ 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:  & 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…