Quality Systems Engineer

Quality Systems EngineerSolventum, a new healthcare company with a rich history We're a new 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.The impact you'll make in this roleAs 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 improvementEnsuring compliance to relevant regulations and standardsCreating and supporting QMS document control and document change processes.Communicating with the manager about compliance issues or if a negative trend is identifiedHosting customer audits and regulator inspections for the siteLeading internal auditsSupporting reporting and system use/training as neededProcessing document changes in an efficient and timely mannerEnsuring accuracy and completeness of documentsEnsuring documents accessible through the controlled document management systemEnsuring document controls in place for technical accuracy and reviewFollowing global and business processes and proceduresInterpreting regulations and representing the customer to foster a quality culture and mindset throughout the plant.Your skills and expertiseThese are the core capabilities and experiences essential to make an impact:Bachelor of Science degree (completed and verified prior to start) AND 5 years of experience in Quality Management Systems (QMS) or equivalent regulated environment.ORHigh School Diploma/GED AND 8 years of Quality Management Systems (QMS) experienceNice to Have Qualifications:ISO 13485, ISO 9001, and/or pharmaceutical audit and inspection experienceISO 13485 Lead Auditor CertificationTechnical writing skillsCAPA writing and coaching experienceWork Location: Onsite: Maryland Heights, Missouri LocationTravel: May include up to 10% travel within sales territoryRelocation Assistance: May be authorizedPay TransparencyApplicable 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: & ComplianceMust be legally authorized to work in the country of employment without sponsorship for employment visa status.Where this role fitsThis 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.Responsibilities of this position include that corporate policies, procedures and security standards are complied with while performing assigned duties.Solventum is committed to maintaining the highest standards of integrity and professionalism in our recruitment process. Applicants must remain alert to fraudulent job postings and recruitment schemes that falsely claim to represent Solventum and seek to exploit job seekers.Please note that all email communications from Solventum regarding job opportunities with the company will be from an email with a domain of @solventum.com. Be wary of unsolicited emails or messages regarding Solventum job opportunities from emails with other email domains.Solventum is an equal opportunity employer. Solventum will not discriminate against any applicant for employment on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status.Please note: your application may not be considered if you do not provide your education and work history, either by: 1) uploading a resume, or 2) entering the information into the application fields directly.Solventum Global Terms of Use and Privacy StatementCarefully read these Terms of Use before using this website. Your access to and use of this website and application for a job at Solventum are conditioned on your acceptance and compliance with these terms.Please access the linked document by clicking here. Before submitting your application you will be asked to confirm your agreement with the terms.