Global Corrective and Preventive Quality Analyst

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as a subject matter expert and mentor regarding Corrective and Preventive Action (CAPA) requirements, methodologies, and processes.

• Perform independent evaluations of CAPA records and offer constructive feedback to enhance the quality of investigations, root cause analysis, corrective actions, and overall compliance.

• Assist in global CAPA governance initiatives, which include CAPA Review Boards, escalation procedures, and risk-based decision-making.

• Create and deliver training sessions, coaching, guidance documents, and best practice resources to enhance CAPA knowledge and capabilities throughout the organization.

• Track, analyze, and report on CAPA metrics and trends to identify areas for continuous improvement and support management review processes.

• Aid in the deployment, adoption, and ongoing enhancement of QMS processes, systems, tools, and metrics across global locations.

• Adhere to corporate policies, procedures, and security standards while executing assigned responsibilities.

⛳️ Requirements

• Bachelor’s Degree or higher with four (4) years of relevant experience in quality processes related to investigations, problem-solving, and project management; OR a High School Diploma/GED with eight (8) years of relevant experience in quality processes involving investigations, problem-solving, and project management.

• Familiarity with both domestic and international quality and auditing standards, such as ISO 13485, ISO 19011, FDA Quality System Regulations, CMDR, and EU MDR.

• Knowledge of CAPA governance, facilitating investigations, leading problem-solving efforts, and guiding stakeholders through corrective and preventive action processes.

• Excellent technical writing, analytical thinking, communication, problem-solving, and investigative skills, including experience with root cause analysis and quality improvement methodologies.

• Proven ability to collaborate effectively across different functions, cultures, and global locations, while fostering strong relationships with stakeholders.

• Capability to develop and provide training, guidance materials, and presentations to varied global audiences.

• Must have legal authorization to work in the 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