Responsibilities : This consultant will be responsible for assisting with integration and remediation efforts from audit findings that need to be addressed from a prior acquisition. This candidate should be comfortable in a jack-of-all-trades quality engineering perspective, specifically focused on manufacturing support and supplier quality support, as well as familiar with design quality work as well. They will be dealing with nonconformance's, CAPAs, IQ/OQ/PQs, investigations, and supporting the design history file review. There are expected to be some findings from an internal audit that was recently performed, and this individual will be addressing those findings. They will also be responsible for reducing metrics, handling investigations, supplier quality integrations, and running cross functional team meetings. This person will also be dealing with qualifications, sample sizing, and supporting cross functionally for other engineers working on the design history file remediation. They will also be assisting with supplier qualification files, as well as assisting with the backlog of supplier filings, making sure suppliers are up to date, and making sure supplier. This person should be self-sufficient, capable of working cross functionally, and must be able to hit the ground running in a fast-paced remediation environment. Requirements: Medical Device Manufacturing Supplier Quality Nonconformances / CAPAs Remediation / Integration IQ/OQ/PQ Internal audit response experience
Katalyst Healthcares and Life Sciences
05/03/2024
Baltimore,MD