Acera Quality Engineer

Solventum•Saint Louis, MO

23d•Onsite

About The Position

Solventum is a new healthcare company with a rich history, 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 an Acera Quality Engineer you’ll work alongside sharp, inquisitive minds from a wide spectrum of backgrounds and disciplines. Together, you'll explore new ideas, challenge assumptions, and shape solutions that make a real-world impact.

Requirements

Bachelor’s Degree or higher from an accredited university
3+ years of experience in quality engineering, quality assurance, or quality management within the medical device industry

Nice To Haves

Knowledge of ISO 13485, FDA regulations, and other applicable quality standards
Experience supporting or participating in internal and external audits
Strong analytical, problem-solving, communication, and organizational skills
Detail-oriented with the ability to work independently and collaboratively within a team environment

Responsibilities

Review, approve, and maintain manufacturing batch records and quality documentation for production, testing, sterilization, and validation activities.
Support and maintain the Quality Management System (QMS) in compliance with ISO 13485, FDA regulations, and medical device quality standards.
Manage documentation control, calibration records, preventive maintenance tracking, and records management processes.
Execute and support test method validations, risk assessments, CAPA activities, and continuous quality improvement initiatives.
Conduct and support internal and external audits, inspections, and corrective action follow-up to ensure regulatory compliance.
Provide QMS and quality standards training to employees, including development of training materials for new and existing staff.
Collaborate with cross-functional teams including manufacturing, R&D, regulatory affairs, and external stakeholders to resolve quality issues and communicate performance metrics.