Acera Quality Engineer

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 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 by:

• 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.

Your skills and expertise

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

Required Qualifications:

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

Nice to Have” Qualifications:

• 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

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 $110,000.00 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: https://www.solventum.com/en-us/home/our-company/careers/#Total-Rewards

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 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 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.