SlipstreamJobs tracks this role from the company's public career site. Apply directly on the employer's site.
Salary: USD 106,800 - 202,900 / annual
This role provides site-level CAPA (Corrective and Preventive Action) mentorship, oversight, and approval support across the quality system at a medical device company. You will partner 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 managing and overseeing the CAPA portfolio, monitoring and tracking CAPA health, compliance, and performance metrics for Quality leadership. You will 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. You will provide subject-matter expertise on structured problem-solving methodologies and ensure effective execution of the CAPA process across all phases.
You will 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. Collaboration with Quality Assurance, Project Management, and functional leaders is essential to identify systemic quality issues and drive continuous improvement initiatives. You will provide CAPA status updates, milestone tracking, and risk assessments to Project Managers and stakeholders for assigned projects, review and approve CAPA records and phases, and participate in Community of Practice meetings as needed.
Minimum qualifications include a Bachelor's degree and a minimum of 7 years of experience supporting nonconforming events and CAPA within a regulated environment (FDA, ISO standards, EU MDR, ISO 13485). You must have demonstrated experience leading or mentoring cross-functional teams through nonconforming events and CAPA implementation, with strong written and verbal communication skills and proven problem-solving, organizational, and execution abilities.
Preferred qualifications include broad working knowledge of quality systems and processes (CAPA, NCRs, audits, complaints), quality-related certifications (ISO 13485, AS9100), and subject-matter expertise in CAPA regulations and nonconforming event management.
