Sr Quality Analysis - CAPA Mentor

Sr Quality Analysis - CAPA Mentor

This role provides site-level CAPA mentorship, oversight, and approval support across the quality system. The CAPA Mentor partners with CAPA owners, project teams, and Quality leadership to ensure timely, compliant, and effective corrective and preventive actions, while driving continuous improvement and risk reduction.

Key responsibilities include, but are not limited to, the following:

• Manage and oversee the CAPA portfolio, including monitoring, tracking, and reporting CAPA health, compliance, and performance metrics to Quality leadership.
• Serve as a CAPA Mentor by coaching and guiding cross-functional teams through nonconforming events and the development, implementation, and verification of corrective and preventive actions.
• Provide subject-matter expertise on structured problem-solving methodologies and effective execution of the CAPA process across all phases.
• Partner with CAPA owners to ensure CAPA records are compliant with global and local procedures, clearly written, logically structured, and aligned with the intent of each CAPA activity, including appropriate documentation of rationale and decision-making.
• Collaborate with Quality Assurance, Project Management, and functional leaders to identify systemic quality issues and drive continuous improvement initiatives.
• Provide CAPA status updates, milestone tracking, and risk assessments to Project Managers and stakeholders for assigned projects.
• Review and approve CAPA records and phases, as applicable, ensuring compliance with global CAPA requirements and quality system expectations.
• Participate in Community of Practice meetings for nonconforming events and CAPA as needed.
• Participate in projects as needed.

Minimum Qualifications:

• Bachelor's degree required.
• Minimum of 5 years of experience supporting nonconforming events and CAPA within a regulated environment.
• Experience working in regulated industries (e.g., FDA, ISO standards, EU MDR, ISO 13485).
• Demonstrated experience leading or mentoring cross-functional teams through nonconforming events and CAPA implementation.
• Strong written and verbal communication skills with a high level of attention to detail.
• Proven problem-solving, organizational, and execution skills.

Preferred Qualifications:

• Broad working knowledge of quality systems and processes (e.g., CAPA, NCRs, audits, complaints).
• Quality-related certifications (e.g., ISO 13485, AS9100).
• Subject-matter expertise in CAPA regulations and nonconforming event management.