Quality Specialist, Solventum (Formerly 3M Health Care)

Benefits

Additional Information

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: Quality Specialist 3M Health Care is now Solventum At 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 Role As a Senior Quality Specialist, 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: Manage inspection processes to ensure compliance with local regulatory requirements and corporate quality standards Oversee nonconforming product and process management, collaborating cross‑functionally to drive improvement in NC metrics Develop and implement corrective and preventive actions (CAPA) in partnership with relevant departments Act as Process Owner and System Super User for NC-related systems, including site user management Manage Quality Hold notifications and disposal processes to ensure timely and compliant execution Provide end‑to‑end oversight of the labeling process, including evaluation of operational methods and development of quality control processes Set and manage SAP restriction controls prior to the completion of required quality activities Communicate with 3PL partners, providing clear quality direction to align distribution center (DC) quality processes Manage distributor quality by: Communicating quality requirements Driving implementation of corporate quality metrics Identify batches requiring QC testing and coordinate sampling and testing activities with external laboratories Introduce and manage QC testing methods at testing laboratories in accordance with approved license information Manage QC testing reports within the document management system (DMS) Oversee QC sample management, including continuous process improvement Manage QC sample adjustments within the distribution process Manage external testing laboratories to ensure alignment with local regulations and corporate requirements Participate in or initiate quality improvement projects Drive continuous improvement initiatives to enhance overall distribution and QC quality performance Support internal and external audits Your 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 in a science or engineering discipline from an accredited institution AND 5 years of experience developing, supporting and/or maintaining full Quality management system. In addition to the above requirements, the following are also required: Combined experience in medical device and/or pharmaceutical industry (healthcare) Quality Management Systems (QMS) such as ISO13485, GMP. Strong communication skills, written and oral for internal/ external (including regulators) Korean/ English proficiency An advanced capability to comprehend regulatory requirements and company quality policy and procedures Strong attention to detail, organizational skills, and ability to manage multiple projects simultaneously. Leaning agility allowing the acquisition of such knowledge in a timely manner Advanced MS Office skills Additional qualifications that could help you succeed even further in this role include: Combined experience in medical device and/or pharmaceutical industry (healthcare) Quality Management Systems (QMS) such as ISO13485, GMP. Competen