Quality Systems Engineer

SOLVENTUM•St. Louis, MO

2d•$90,000 - $110,000•Onsite

About The Position

Solventum, a new healthcare 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. 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.

Requirements

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

Nice To Haves

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

Responsibilities

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.
Corporate policies, procedures and security standards are complied with while performing assigned duties.