Roles & Responsibilities: Prior experience working in Supplier Quality. Excellent technical writing skills. Prior experience initiating/writing, evaluating and completing Corrective and Preventive Actions (CAPA). Work experience in a medical device/ pharmaceutical environment. Familiarity with 21 CFR 820, ISO 9001:2015, and ISO 13485:2016. Strong background and proven experience in Data Analytics. Strong experience in Power BI (Dashboard creation, data visualization). Certified Lead (External) Auditor.