Quality Systems Engineer

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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.

• 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.

These are the core capabilities and experiences essential to make an impact:

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

• ISO 13485, ISO 9001, and/or pharmaceutical audit and inspection experience
• ISO 13485 Lead Auditor Certification
• Technical writing skills
• CAPA writing and coaching experience

Onsite:
Maryland Heights, Missouri

May include up to 10% travel within sales territory

May be authorized

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:

Must be legally authorized to work in the country of employment without sponsorship for employment visa status.

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…