Quality Systems Engineer

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:

• ✓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

Work Location: Onsite: Maryland Heights, Missouri Location

Travel: May include up to 10% travel within sales territory

Relocation Assistance: May be authorized

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.

of this position include that corporate policies, procedures and security standards are complied with while performing assigned duties.

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