Katalyst Healthcares and Life Sciences
Roles & Responsibilities
- Minimum six years of experience in a manufacturing environment, preferably in a foundry for Medical Product.
- Manufacturing Engineer, Foundry, Packaging, Cleanroom, Equipment validation, Process Validation, IQ, OQ, PQ, Product transfer and Manufacturing transfer.
- Has worked in a Packaging, Cleanroom, Equipment machine shop environment (within med device or aerospace preferred).
- Product / Manufacturing Transfer activities.
- Good experience validations (IQ/OQ/PQ).
- Understanding of different types of metal/plastic cutting manufacturing processes.
- Basic understanding of Packaging, clean room, milling and or lathe machines• Understanding of basic Quality systems.
- Experience in FDA Regulations and ISO Standards: 21 CFR, Quality system regulation (Part 820), establishment registration (Part 807), and unique device identification (Part 830).