QA Specialist III

• 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 an FDA-regulated environment
• Familiarity with CFR 820, ISO 9001:2015, and ISO 13485:2016
• Strong background in Data Analytics
• Strong experience in PowerBI (Dashboard creation, data visualization)

Preferred Experience: Certified Lead (External) Auditor

Description:

• This position is NonExempt. Hours over 40 will be paid at Time and a Half.
• Assures the quality of manufactured products and processes per standard operating processes(SOP'S) and GMP (Good Manufacturing Practices).

BS degree and/or 5 years equivalent experience