Acera Quality Engineer

Solventum is a healthcare company focused on solving big challenges that improve lives and help healthcare professionals perform at their best. Guided by empathy, insight, and clinical intelligence, we collaborate with the best minds in healthcare to address the toughest challenges. Acera Quality Engineer As a Quality Engineer for the Acera product portfolio, you will work alongside cross‑functional teams to ensure regulatory compliance and continuous quality improvement. 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. Qualifications Required: 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: 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 & Travel Onsite: Maryland Heights, Missouri. Travel may include up to 10% within sales territory. Compensation & Benefits Salary range: $90,000.00 to $110,000.00, with additional bonus opportunities based on performance. Eligible for a range of benefits including medical, dental, vision, health savings account, dependent care flexible spending account, disability benefits, life insurance, voluntary benefits, paid absences, and retirement benefits. Legal & Compliance Must be legally authorized to work in the country of employment without sponsorship for employment visa status. As it was with 3M, at Solventum all qualified applicants will receive consideration for employment without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. #J-18808-Ljbffr