What are the responsibilities and job description for the QA Specialist III - Medical Devices position at TekOne IT Services Pvt. Ltd.?
Role: QA Specialist III
Location: Des Plaines, Illinois - 60018-3315
Duration: 09 Months
Job Description
Location: Des Plaines, Illinois - 60018-3315
Duration: 09 Months
Job Description
- 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)
- Certified Lead (External) Auditor
- 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