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 an Area 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 and govern the company’s document control system (ENOVIA), ensuring review step compliance with local requirements.

• Monitor, analyze, and drive performance against key quality KPIs, ensuring timely disposition and continuous improvement.

• Lead cross-functional investigations and manage the development, implementation, and effectiveness monitoring of Corrective and Preventive Actions (CAPAs).

• Conduct annual site risk assessments, develop, execute, and oversee internal audit and self-inspection programs. Supports external audits per Technical Director instructions and global procedures.

• Deliver training and qualification programs to employees on QMS requirements and quality processes.

• Partner with the Technical Director to ensure ongoing compliance with applicable regulatory, quality, and operational requirements.

• Support product release activities, including oversight of Certificates of Analysis (CoAs) and related quality documentation.

• Manage change control processes, including documentation, impact assessment, implementation, and effectiveness tracking.

• Act as the designated backup for the Technical Director, ensuring uninterrupted oversight of quality and regulatory compliance activities when required.

• Undertake additional responsibilities as assigned by management to support organizational priorities and continuous improvement initiatives.

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 in Pharmacy, Pharmaceutical Sciences, Life Sciences, Healthcare, or a related field (completed and verified prior to start date).

• Minimum of three (3) years of experience maintaining Quality Management Systems (QMS) and Good Distribution Practices (GDP) within Medical Devices and/or Pharmaceutical environments.

• Intermediate to advanced English proficiency, with the ability to communicate effectively in a global environment.

• Strong knowledge of Medical Device and Pharmaceutical regulations, including Good Storage, Distribution, and Transportation Practices.

• Experience conducting internal audits, risk assessments, CAPA management, change controls, and regulatory inspections. 

Additional qualifications that could help you succeed even further in this role include: 

• Statistics and data analysis for quality performance monitoring and continuous improvement.

• Experience in Regulatory Affairs within regulated healthcare industries.

• Knowledge of Integrated Management Systems (IMS), Good Manufacturing Practices (GMP), and Corrective and Preventive Actions (CAPA).

• Familiarity with Colombian regulatory requirements for Medical Devices and Pharmaceuticals. 

 Work location:  Hybrid (Solventum office and at the 3PL in Cundinamarca)

Travel: May include up to 10% in country 

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.