Global Corrective and Preventive (CAPA) Quality Analyst (Solventum) at Solventum in Remote-United States

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.
• 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.

Responsibilities

• 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.

Requirements

• 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.

Skills

Required

• Communication
• Collaboration
• Analytical thinking
• Problem-solving
• Coaching
• Technical writing
• ISO 13485
• ISO 19011
• FDA Quality System Regulations
• CMDR
• EU MDR
• CAPA governance

Benefits

• 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