Global Quality

Thank you for your interest in joining Solventum. Solventum is a new healthcare company with a long legacy of solving big challenges that improve lives and help healthcare professionals perform at their best. At Solventum, people are at the heart of every innovation we pursue. Guided by empathy, insight, and clinical intelligence, we collaborate with the best minds in healthcare to address our customers’ toughest challenges. While we continue updating the Solventum Careers Page and applicant materials, some documents may still reflect legacy branding. Please note that all listed roles are Solventum positions, and our Privacy Policy: https://www.solventum.com/en-us/home/legal/website-privacy-statement/applicant-privacy/ applies to any personal information you submit. 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.Job Description:3M Health Care is now SolventumAt Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers’ toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the better while enabling healthcare professionals to perform at their best. Because people, and their wellbeing, are at the heart of every scientific advancement we pursue. We partner closely with the brightest minds in healthcare to ensure that every solution we create melds the latest technology with compassion and empathy. Because at Solventum, we never stop solving for you.The Impact You’ll Make in this RoleAs a Global Field Action Coordinator (m/f/x)*, you will play a critical role in managing worldwide product field actions, ensuring compliance with regulatory requirements, and driving cross-functional execution. This role requires strong leadership, organizational, and regulatory expertise to safeguard patients and maintain compliance. Here, you will make an impact by:Leading global field action execution, chair field action committees, and work cross-functionally with regional/country field action leads, ensuring communication dissemination, notifications and responses are accurate, timely, and in alignment with global regulationsOverseeing preparation, approval, and submission of all required documentation (e.g., Field Action Letters, reports, checklists) and maintain accurate records in electronic system of record (PLM).Directing global communication and Health Authority notifications, ensuring timely and compliant reporting with objective evidence of completionManaging logistics of product returns in collaboration with Logistics Quality, monitoring and tracking dispositions, and effectiveness checks; confirming all corrective/removal actions are effective prior to closurePartnering with Quality Management Representatives, Technical Service Centers, and senior leadership on field action strategies, correspondence, and periodic updatesYour Skills and Expertise  To set you up for success in this role from day one, Solventum requires (at a minimum) the following qualifications:Bachelor’s Degree or higher and minimum 5 years of Quality experience in a regulated environmentFamiliarity with standards, regulations, and competent authorities such as US 21 CFR 210, 211, and 820, ISO 13485, ISO 9001, EU MDR, IVDR, Health Canada, ANVISA, COFEPRIS, MHRA, TGA, NMPA, PMDA, etc.Experience executing global processes, engaging with cross-functional and global subject matter experts and stakeholders to assign tasks, monitor timelines and drive actions forwardAbility to lead without authority, similar to a project manager roleMinimum of 3 years of responsibility for managing and tracking recalls/ Field Action responses and updates to regulatory agencies, ensuring timely submissions and updates to the appropriate regulatory authoritiesDirectly support the Global Process Owner with the governance, monitoring, and execution of the Global Field Action quality sub-systemAdditional qualifications that could help you succeed even further in this role include:Working with international locations and businessesEngaging with global regulatory agencies, competent authorities, notified bodiesSkills including:Ability to manage without authority, highly organized and able to operate effectively to (sometimes tight) deadlinesStrong and well-developed interpersonal communication skills (written and verbal)Very strong and well-developed written communication skills with regulatory authorities globally (heavy focus on FDA)Technical writing skills specific to Field Action documentationWork location:  Remote – Poland (proximity to Wroclaw if possible)Travel: May include up to 10% (domestic/international)Relocation Assistance: May be authorizedMust be legally authorized to work in the country of employment without sponsorship for employment visa status (e.g., H1B status).Supporting Your Well-being Solventum offers many programs to help you live your best life – both physically and financially. To ensure competitive pay and benefits, Solventum regularly benchmarks with other companies that are comparable in size and scope. Diversity & Inclusion(*) We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, gender, sexual orientation, age, civil status, disability, family status, or membership of the travelling community. 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.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, select the country where you are applying for employment, and review. Before submitting your application you will be asked to confirm your agreement with theterms.