Global Corrective and Preventive (CAPA) Quality Analyst (Solventum)

Solventum; Northern (KY); Hybrid; USD 96,000 - 132,000; Full time

Job summary

Solventum is seeking a Global CAPA Quality Analyst to lead CAPA investigations, root cause analyses, and corrective actions across global sites. You will coach stakeholders, support governance boards, and help advance QMS processes with data-driven insights.

The role requires strong technical writing, cross-functional collaboration, and the ability to deliver training to diverse audiences worldwide. Remote-USA with up to 25% travel may be required.

Qualifications

• Bachelor’s degree and 4 years in quality investigations, problem solving, and project management.
• High school diploma with 8 years in quality investigations, problem solving, and project management.
• Experience with ISO 13485 / FDA QSR / CAPA governance is a plus.

Responsibilities

• Serve as a subject matter expert for CAPA requirements, methodologies, and processes.
• Lead investigations, root-cause analysis, and corrective actions with quality improvement focus.
• Support global CAPA governance activities, including Review Boards and risk-based decisions.
• Develop and deliver training, guidance documents, and best-practice CAPA resources across the organization.
• Monitor CAPA metrics and trends to drive continuous improvement and management review.

Skills

CAPA knowledge

Root cause analysis

Quality investigations

Project management

Training delivery

Education

Bachelor’s degree or higher

High School Diploma/GED alternative

Job description

**Global Corrective and Preventive (CAPA) Quality Analyst (Solventum)** **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 Global Corrective and Preventive (CAPA) Quality Analyst 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: * Serving as a subject matter expert and coach for Corrective and Preventive Action (CAPA) requirements, methodologies, and processes.* Conducting independent reviews of CAPA records and providing feedback to improve investigation quality, root cause analysis, corrective actions, and overall compliance.* Supporting global CAPA governance activities, including CAPA Review Boards, escalation processes, and risk-based decision making.* Developing and delivering training, coaching, guidance documents, and best-practice resources to strengthen CAPA knowledge and capability across the organization.* Monitoring, analyzing, and reporting CAPA metrics and trends to identify opportunities for continuous improvement and support management review activities.* Supporting deployment, adoption, and continuous improvement of QMS processes, systems, tools, and metrics across global sites.**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 AND four (4) years of previous experience in quality processes involving investigations, problem solving, and project management. OR * High School Diploma/GED AND eight (8) years of previous experience in quality processes involving investigations, problem solving, and project management. Additional qualifications that could help you succeed even further in this role include: * Understanding of domestic and international quality and auditing requirements, including ISO 13485, ISO 19011, FDA Quality System Regulations, CMDR, and EU MDR.* Knowledge of CAPA governance, facilitating investigations, leading problem-solving activities, and coaching stakeholders through corrective and preventive action processes.* Strong technical writing, analytical thinking, communication, problem-solving, and investigation skills, including experience with root cause analysis and quality improvement methodologies.* Demonstrated ability to collaborate effectively across functions, cultures, and global locations while building strong stakeholder relationships.* Ability to develop and deliver training, guidance materials, and presentations to diverse global audiences.**Work location:*** **Remote- USA** **Travel: May include up to 25% domestic or international****Relocation Assistance: No** **Must be legally authorized to work in 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.Applicable to US Applicants Only:The expected compensation range for this position is $96,000 - $132,000, which includes base pay plus variable incentive pay, if eligible. 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: https://www.solventum.com/en-us/home/our-company/careers/#Total-Rewards 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.Please note, Solventum does not expect candidates in this position to perform work in the unincorporated areas of Los Angeles County.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.**