Business Associate at Redheart Solutions
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Quality Engineer - Sterile (3-10 yrs)
1. Experience in the medical device, life science, biopharmaceuticals industry, or other related regulated areas. Experience in sterile device/biopharmaceuticals manufacturing is a must.
2. Detailed understanding of the common processes in production as well as general business practices within the regulated field.
3. Familiar with relevant regulatory statutes and industry standards, such as ISO 13485, GMP.
4. Strong experience in process control, nonconforming, CAPA, complaint handling, reporting, and trending
5. Knowledge of quality control, process/equipment validations.
6. Knowledge of quality system requirements such as ISO/GMP. ISO13485 certificate is an additional benefit
7. Qualified auditor with excellent audit skills preferred
8. Proficiency in MS Word, Excel, Power Point, etc