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Validation

Company:
Deegit Inc
Location:
Spring Lake Park, Minnesota, 55432, United States
Posted:
September 15, 2017
Description:

Validation

spring lake park, MN

6+Months

JD:

• Prior medical device manufacturing background and experience required.

• Ability to review Design Validation /Specifications /documents /Drawings / Details Data collection in EU MDD Tech files

• Hazard Analysis / Component Design FMEA / review /verification / Updation

• Experience in Agile, Documentum or any document management system

• Experience in Process FMEA/ Risk management CAPA and RCA and provide inputs to Design team.

• Validation documentation against production processes and systems in compliance to internal and external requirements utilizing well developed technical and regulatory skills.

• Proven ability of working in a cross-functional team environment. Demonstrated ability to effectively work cross functionally with other departments including Operations, Product Development, QA, etc. as necessary.

• Communicate significant issues or developments identified during production, validation and qualification activities.

• Knowledge on ISO 13485/Part 820 / ISO 14971 will be preferred.