Workstream: Quality Management System (QMS) Remediation

Role: CAPA Remediation Specialist Role Summary The CAPA Remediation Specialist is an individual contributor responsible for executing activities that support FDA interim controls and Corrective and Preventive Action (CAPA) processes.

This role works closely with the QMS Remediation Leader and the CAPA subject matter expert to carry out day-to-day CAPA tasks, complete remediation activities and help maintain the effectiveness of the CAPA system. The successful candidate is a hands-on contributor who follows established procedures, applies sound problem-solving and ensures accurate, timely completion of assigned CAPA and quality system work. The role requires an understanding of the quality management system, federal regulation and applicable standards, and good judgment in selecting methods and techniques for obtaining solutions under general guidance.

Responsibilities Support colleagues on BSHS quality system requirements and standards to elevate the team's ability to produce high-quality products, and implement best practices that emphasize defect prevention, reduction in variation and waste, and continuous improvement.

Collaborate and communicate effectively with employees, peers and cross-functional teams across all levels of the organization.

Support the Interim CAPA Review Board for BSHS as needed.

Review open, active CAPAs, guiding the organization in root cause analysis, effectiveness checks and sustainable corrective actions.

Partner with the QMS Remediation Leader and CAPA subject matter expert to redesign and implement robust CAPA processes aligned with regulatory requirements and business objectives.

Contribute to CAPA-related remediation projects, ensuring timely and thorough resolution of systemic issues.

Provide consultation, feedback and training on CAPA principles,



methodologies and best practices to quality management system and cross-functional teams.

Perform consistent reviews of the CAPA system to determine escalations, and coordinate with departments to ensure adequate resourcing.

Network with internal and external stakeholders to benchmark and implement industry-leading CAPA practices.

Modify, maintain and implement procedures and processes as applicable.

Drive implementation of sustainable controls, metrics and monitoring mechanisms to prevent recurrence of issues.

Coordinate documentation and activities stemming from site CAPA Review Board meetings.

Promote a culture of quality, accountability and continuous improvement.

Qualifications Technical bachelor's degree.

Two to four years of relevant experience with a technical bachelor's degree.

Strong working knowledge of FDA 21 CFR 820 and ISO 13485, with a medical device emphasis.

Experience supporting remediation in response to audits, inspections or enforcement actions, or continuous improvement initiatives.

Proven ability to work across cross-functional teams and manage multiple workstreams.

Strong written and verbal communication skills, including executive-level updates and regulatory documentation.

Excellent technical writing skills and the ability to present materials to director-level leadership.

Strong analytical and problem-solving skills, highly organized, with the ability to manage complex, multi-threaded remediation efforts.

Detail-oriented with a focus on compliance, sustainability and effectiveness.

Proactive, adaptable and comfortable operating in high-visibility, fast-paced environments.

Fluent in English, written and verbal.

Preferred Qualifications Experience with Agile or an equivalent product lifecycle management system.

Understanding of statistics and statistical analysis.

Reporting Structure

Reports to: QMS Remediation Leader

📌 CAPA Remediation Specialist (México)
🏢 QvalFocus
📍 México