Remediation CAPA Engineer

Job summary

The Remediation CAPA Engineer is responsible for supporting the execution and remediation of Nonconformance (NC) and Corrective and Preventive Action (CAPA) processes, ensuring compliance with quality system requirements and regulatory standards. This role involves collaboration across functions and sites to maintain timely and compliant remediation actions.

Qualifications

• Bachelor’s Degree in Science, Engineering, or a related field.
• Minimum of 5 years of experience in supporting NC/CAPA processes in the medical device or healthcare sector.
• Expert proficiency in TrackWise.
• Comprehensive understanding of ISO 13485:2016, 21 CFR Part 820, and MDSAP.

Responsibilities

• Assist in the remediation and execution of NC and CAPA activities in line with established procedures and regulations.
• Review NC and CAPA records for accuracy and compliance, ensuring timely progression.
• Provide support to NC/CAPA Owners regarding record content and remediation expectations.
• Prepare metrics and reports for Quality Systems leadership and CAPA Review Boards.
• Collaborate with cross-functional teams on high-priority NC and CAPA records.
• Participate in NC/CAPA escalation meetings, providing updates and follow-ups.
• Support TrackWise system activities, including data clean-up and user support.

Skills

• Strong problem-solving and data analysis skills with attention to detail.
• Knowledge of statistical techniques and their applications.
• Effective communication skills, both verbal and written, in English and Spanish.
• Ability to work independently and produce quality work without close supervision.

Tools

Working Conditions

• Proficient in MS Office (Outlook, PowerPoint, Word, Excel), Microsoft Teams, and Adobe Acrobat Pro.
• This position requires on-site presence based on the activities being executed, with potential domestic and international travel of 30-50%.