Global Corrective and Preventive Quality Analyst

🔥 13 hours ago

🇺🇸 United States – Remote

💵 $96k - $132k / year

⏰ Full Time

🟠 Senior

🔴 Lead

🧐 Analyst

👻 Ghost score 0%

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Solventum

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

📦 Logistics

💼 Consulting

Healthcare • Logistics • Consulting

Solventum is a healthcare-focused company renowned for its innovative solutions aimed at improving medical and oral care outcomes. The company offers a variety of medical technologies, including advanced wound care, surgical solutions, and sterilization products. Solventum also provides advanced oral care solutions, health information and technology services, and purification and filtration products for biopharmaceutical applications. Furthermore, Solventum places a strong emphasis on sustainability and education, providing resources and training for healthcare professionals globally. Their commitment to innovation and better healthcare has made them a leader in the healthcare industry, dedicated to enhancing patient safety and healthcare efficiencies.

📋 Description

• Serve as a subject matter expert and coach for Corrective and Preventive Action (CAPA) requirements, methodologies, and processes • Conduct independent reviews of CAPA records and provide feedback to improve investigation quality, root cause analysis, corrective actions, and overall compliance • Support global CAPA governance activities, including CAPA Review Boards, escalation processes, and risk-based decision making • Develop and deliver training, coaching, guidance documents, and best-practice resources to strengthen CAPA knowledge and capability across the organization • Monitor, analyze, and report CAPA metrics and trends to identify opportunities for continuous improvement and support management review activities • Support deployment, adoption, and continuous improvement of QMS processes, systems, tools, and metrics across global sites • Comply with corporate policies, procedures, and security standards while performing assigned duties

🎯 Requirements

• 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 • 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 • Must be legally authorized to work in country of employment without sponsorship for employment visa status

🏖️ Benefits

• Medical, Dental & Vision • Health Savings Accounts • Health Care & Dependent Care Flexible Spending Accounts • Disability Benefits • Life Insurance • Voluntary Benefits • Paid Absences • Retirement Benefits • Up to 25% domestic or international travel may be included