Supports remediation and execution of Nonconformance (NC) and CAPA activities in accordance with established procedures and global regulatory requirements (e.g., FDA 21 CFR Part 820, ISO 13485).
Reviews NC and CAPA records for completeness, accuracy, and procedural compliance, and supports timely routing and progression of records.
Provides hands‑on support to NC/CAPA Owners and Leads on record content, remediation expectations, and appropriate use of the NC/CAPA system.
Prepares metrics, reports, and data summaries to support oversight by Quality Systems leadership and CAPA Review Boards.
Supports cross‑functional teams with remediation of high‑priority, overdue, or inspection‑critical NC and CAPA records.
Participates in NC/CAPA escalation and board meetings in a supporting role, including status updates and follow‑up of assigned actions.
Assists with NC/CAPA TrackWise system activities, including data clean‑up, user support, and validation tasks (e.g., user acceptance testing), as assigned.

Bachelor’s Degree in Science, Engineering, or related discipline.
Minimum 5 years supporting a Non-Conformance/CAPA process in the medical device or healthcare industry.
Expert skill level utilizing TrackWise.
Knowledge of and the ability to translate and apply the requirements of ISO 13485:2016, 21 CFR Part 820, and the Medical Device Single Audit Program (MDSAP).
Ability to deal with difficult situations with tact and professionalism.
Ability to communicate effectively in both oral and written communications, and work with employees at all levels of the organization.
Demonstrate problem solving and trouble shooting skills.
Strong computer skills: MS Office (Outlook, PowerPoint, Word, and Excel), Microsoft Teams, and Adobe Acrobat Pro.

Remediation CAPA Engineer

Key skills